Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- K251596Lunderquist Extra Stiff Wire Guide2Cleared 510(K)
- K250203SureAx-Guide™2Cleared 510(K)
- K250031Amplatzer Guidewire2Cleared 510(K)
- K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)2Cleared 510(K)
- K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire2Cleared 510(K)
- K250075Medtronic Stedi Extra Support Guidewire2Cleared 510(K)
- K243733SION blue PLUS2Cleared 510(K)
- K241962Crossloop2Cleared 510(K)
- K242597CROSSLEAD 0.018inch2Cleared 510(K)
- K241702CROSSLEAD 0.014inch2Cleared 510(K)
- K241521Prelude Small O.D. Introducer Guide Wire2Cleared 510(K)
- K242824PTFE Guidewire2Cleared 510(K)
- K240818R2P Radifocus Glidewire Advantage2Cleared 510(K)
- K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire2Cleared 510(K)
- K241784Arrow® Nitinol Wire2Cleared 510(K)
- K240859Glidewire GT-R2Cleared 510(K)
- K241510CROSSLEAD Tracker2Cleared 510(K)
- K240387MINAMO blue; MINAMO viola2Cleared 510(K)
- K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)2Cleared 510(K)
- K240864PacePro Wire2Cleared 510(K)
- K232662BNLE Hydrophilic Jacketed Peripheral Guidewire2Cleared 510(K)
- K230418Mighty Wire Guide Wire2Cleared 510(K)
- K232570Steerant™ Super Stiff Guidewire2Cleared 510(K)
- K232578VASSALLO GT 018 G12; VASSALLO GT 018 G302Cleared 510(K)
- K232574VASSALLO GT Crossing142Cleared 510(K)
- K230377CROSSLEAD Penetration Peripheral Guide Wire2Cleared 510(K)
- K223791TalWire2Cleared 510(K)
- K230637Wattson temporary pacing guidewire (2250)2Cleared 510(K)
- K221390BNLE Access Guidewire2Cleared 510(K)
- K223432Vassallo GT 018 Hybrid2Cleared 510(K)
- K213898ProTrack Pigtail Wire2Cleared 510(K)
- K221351Mechanical Guidewire2Cleared 510(K)
- K222631VASSALLO GT EXT2Cleared 510(K)
- K221575Pre-Formed Blue2Cleared 510(K)
- K212615EpiFaith CV2Cleared 510(K)
- K213854SavvyWire2Cleared 510(K)
- K213868ASAHI Gladius Mongo18 PV ES2Cleared 510(K)
- K221917Stent Positioning Assistance System (SPAS)2Cleared 510(K)
- K213315CROSSLEAD Peripheral Guide Wire2Cleared 510(K)
- K213949VASSALLO GT 018 Floppy2Cleared 510(K)
- K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT2Cleared 510(K)
- K210548Medline Integrated Arterial Catheter2Cleared 510(K)
- K220075Spartan Center Wire2Cleared 510(K)
- K213834Cardio Flow Peripheral Guide Wire2Cleared 510(K)
- K220137Lunderquist Extra Stiff Wire Guide2Cleared 510(K)
- K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire2Cleared 510(K)
- K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-202Cleared 510(K)
- K211741Pre-Formed Extra Support Guidewire2Cleared 510(K)
- K203529VASSALLO GT Hybrid2Cleared 510(K)
- K203533VASSALLO GT2Cleared 510(K)
- K210235Verrata PLUS Pressure Guide Wire2Cleared 510(K)
- K201720LiPPS Analyzer, LiPPS Wire Pressure Guide Wire2Cleared 510(K)
- K201595Merit Hydrophilic Guide Wire2Cleared 510(K)
- K193653Hydrophilic Coating Guide Wire2Cleared 510(K)
- K201834HI-TORQUE PROCEED Guide Wire Family2Cleared 510(K)
- K201760Zoom 14 Guidewire2Cleared 510(K)
- K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire2Cleared 510(K)
- K200120LiteSaber Wire Torque Assist Device2Cleared 510(K)
- K200144HI-TORQUE Steelcore Bare Guide Wire2Cleared 510(K)
- K193571Go2Wire Guide Wire2Cleared 510(K)
- K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip2Cleared 510(K)
- K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire2Cleared 510(K)
- K192454Wattson Temporary Pacing Guidewire2Cleared 510(K)
- K192599ASAHI PTCA Guide Wire ASAHI Gaia Next2Cleared 510(K)
- K191907OptoWire III2Cleared 510(K)
- K193194CrossTorq 14 Guidewire2Cleared 510(K)
- K193126HI-TORQUE InfilTrac Guide Wire Family2Cleared 510(K)
- K191502Heraeus Peripheral Guidewire2Cleared 510(K)
- K191464Asahi PTCA Guide Wire Asahi SION Series2Cleared 510(K)
- K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile2Cleared 510(K)
- K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire2Cleared 510(K)
- K190176MINAMO2Cleared 510(K)
- K182985Roadrunner PC Wire Guide, Olcott Torque Device2Cleared 510(K)
- K183062ASAHI Silverway2Cleared 510(K)
- K182457Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J2Cleared 510(K)
- K182553Inno-Pathwire2Cleared 510(K)
- K181353Lunderquist® Fixed Core Wire Guide2Cleared 510(K)
- K183467Roadrunner Extra Support Wire Guide2Cleared 510(K)
- K180830Reuter Tip Deflecting Wire Guide2Cleared 510(K)
- K182315Magic Torque DLVR Guidewire2Cleared 510(K)
- K180177Guidewire2Cleared 510(K)
- K181647Bandit guidewire2Cleared 510(K)
- K180784ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES2Cleared 510(K)
- K173277ASAHI PTCA Guide Wire ASAHI SION black2Cleared 510(K)
- K180726Savion DLVR Guidewire, Savion FLX Guidewire2Cleared 510(K)
- K181351Double Flexible Tipped Wire Guides2Cleared 510(K)
- K181001Medtronic Confida Brecker Guidewire2Cleared 510(K)
- K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire2Cleared 510(K)
- K172187Inno-Hydrowire2Cleared 510(K)
- K171997Mandril Wire Guide2Cleared 510(K)
- K171912Double Flexible Tip Wire Guides2Cleared 510(K)
- K171764Fixed Core Wire Guides2Cleared 510(K)
- K180128Warrior 14 guidewire2Cleared 510(K)
- K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter2Cleared 510(K)
- K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile2Cleared 510(K)
- K173795HI-TORQUE TurnTrac Guide Wire Family2Cleared 510(K)
- K171445Amplatz Support Wire Guide with Apex Curve2Cleared 510(K)
- K171948Roadrunner Extra Support Wire Guide2Cleared 510(K)
- K173532Raider Guidewire2Cleared 510(K)
- K171513Lunderquist Extra Stiff Wire Guide2Cleared 510(K)
- K170915TXM Hydrophilic Guidewire2Cleared 510(K)
- K173423MR Wire Guide Wire Straight, MR Wire Guide Wire Angled2Cleared 510(K)
- K172453WATCHDOG Hemostasis Valve Kit2Cleared 510(K)
- K173052Heraeus TMW Guidewire2Cleared 510(K)
- K170417Glidewire GT2Cleared 510(K)
- K172073Hi-Torque Command 18 Guide Wire2Cleared 510(K)
- K171897Approach CTO Microwire Guide2Cleared 510(K)
- K170532True Form Reshapable Guide Wire2Cleared 510(K)
- K170684Firebow Wire Torque Assist Device2Cleared 510(K)
- K170933Merit Hydrophilic Guide Wire2Cleared 510(K)
- K170700Inqwire Diagnostic Guide Wire2Cleared 510(K)
- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension2Cleared 510(K)
- K170636Fathom-16 Steerable Guidewires2Cleared 510(K)
- K163575Inqwire Diagnostic Guide Wire2Cleared 510(K)
- K163004Radifocus Glidewire Advantage Track2Cleared 510(K)
- K162842ASAHI PTCA Guide Wire ASAHI SUOH 032Cleared 510(K)
- K163444Spectre guidewire2Cleared 510(K)
- K160785Worker Guidewire2Cleared 510(K)
- K161702Endura guidewire2Cleared 510(K)
- K160594MRWire Guide Wire2Cleared 510(K)
- K160643ENROUTE 0.014 Guidewire2Cleared 510(K)
- K153685Sunmed Haemostatic Valves2Cleared 510(K)
- K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®162Cleared 510(K)
- K161887Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip2Cleared 510(K)
- K153397S-Wire Guidewire System2Cleared 510(K)
- K153106ASAHI Fielder XT-A, ASAHI Fielder XT-R2Cleared 510(K)
- K160018Arrow Quickflash Arterial Catheterization Device2Cleared 510(K)
- K153443ASAHI Astato XS 402Cleared 510(K)
- K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire2Cleared 510(K)
- K152991OptoWire Deux2Cleared 510(K)
- K152497PW Guidewires2Cleared 510(K)
- K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire2Cleared 510(K)
- K151234R350 guidewire2Cleared 510(K)
- K152740Radifocus Glidewire2Cleared 510(K)
- K152709HI-TORQUE BALANCE2Cleared 510(K)
- K152404Hi-Torque Command 18 Guide Wire2Cleared 510(K)
- K150465Medtronic Confida Brecker Guidewire2Cleared 510(K)
- K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)2Cleared 510(K)
- K142598Opto Wire and OptoMonitor System2Cleared 510(K)
- K151244Pre-Formed Guidewire2Cleared 510(K)
- K150802Heavy Double Flexible Tipped Wire Guide2Cleared 510(K)
- K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)2Cleared 510(K)
- K143316Attain Hybrid Guide Wire2Cleared 510(K)
- K143135Spring Coil Guidewire2Cleared 510(K)
- K141707ULTRASKIN HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire2Cleared 510(K)
- K142415Hi-Torque JET Guide Wire Family2Cleared 510(K)
- K141218ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM2Cleared 510(K)
- K142051PRELUDE PLASTIC JACKETED GUIDE WIRE2Cleared 510(K)
- K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE2Cleared 510(K)
- K141295MERIT HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K141054DISTAL ACCESS TORQUE DEVICE2Cleared 510(K)
- K142393PREDICATE III GUIDEWIRE2Cleared 510(K)
- K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector2Cleared 510(K)
- K141339ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE2Cleared 510(K)
- K140608MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE2Cleared 510(K)
- K141831HYDRAVIEW GUIDEWIRE2Cleared 510(K)
- K141782HI-TORQUE VERSATURN GUIDE WIRE2Cleared 510(K)
- K140695COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE2Cleared 510(K)
- K140673INSERTION TOOL2Cleared 510(K)
- K133155HYDROPHILIC COATED GUIDEWIRE2Cleared 510(K)
- K140485MANDREL GUIDEWIRE2Cleared 510(K)
- K133865ASAHI GAIA FIRST, SECOND, THIRD2Cleared 510(K)
- K133396VDRIVE WITH V-SONO2Cleared 510(K)
- K132623MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE2Cleared 510(K)
- K133230INQWIRE DIAGNOSTIC GUIDE WIRE2Cleared 510(K)
- K132545MEDIVALVE ACWIRE2Cleared 510(K)
- K123792HORIZON XVU (FFR)2Cleared 510(K)
- K130798PRE-FORMED GUIDEWIRES2Cleared 510(K)
- K131710MERIT HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K122659VDRIVE W/V-SONO2Cleared 510(K)
- K130766ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE2Cleared 510(K)
- K131288VERRATA PRESSURE GUIDE WIRE2Cleared 510(K)
- K130104GUIDEWIRE, PURSUER SERIES2Cleared 510(K)
- K130588MERIT HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K122468ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO2Cleared 510(K)
- K122469ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ2Cleared 510(K)
- K124007SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY2Cleared 510(K)
- K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE2Cleared 510(K)
- K123707ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE2Cleared 510(K)
- K123067PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY2Cleared 510(K)
- K123609MERIT HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K121398CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)2Cleared 510(K)
- K122573HI-TORQUE COMMAND GUIDE WIRE FAMILY2Cleared 510(K)
- K122795STINGRAY GUIDEWIRES2Cleared 510(K)
- K123024TORQUE DEVICE2Cleared 510(K)
- K122856CHARTER GUIDEWIRE2Cleared 510(K)
- K122089OSTIAL PRO STENT POSITIONING SYSTEM2Cleared 510(K)
- K120644MERIT HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K122506SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS2Cleared 510(K)
- K121776AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE2Cleared 510(K)
- K113498DISPOSABLE TORQUE DEVICE2Cleared 510(K)
- K113162SLIDEWIRETM(TRADEMARK PENDING)2Cleared 510(K)
- K121745MANTARAY GUIDEWIRES2Cleared 510(K)
- K112674NAVIS TORQUER2Cleared 510(K)
- K120119SUNMED GUIDE WIRE2Cleared 510(K)
- K120298CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE2Cleared 510(K)
- K120863WHOLEY GUIDE WIRE SYSTEM2Cleared 510(K)
- K120881MANTARAY GUIDEWIRES2Cleared 510(K)
- K11345414 WIRE STANDARD, 14 WIRE LS2Cleared 510(K)
- K120137VICTORY GUIDEWIRE (32 MODELS)2Cleared 510(K)
- K113716ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE2Cleared 510(K)
- K112957HI-TORQUE POWERTURN2Cleared 510(K)
- K112381HI TORQUE CONNECT GUIDEWIRE2Cleared 510(K)
- K112631VSI GUIDEWIRE2Cleared 510(K)
- K112745V-14 CONTROL WIRE GUIDEWIRE2Cleared 510(K)
- K101986ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE2Cleared 510(K)
- K111288ANCHORWIRE GUIDEWIRE2Cleared 510(K)
- K111395PRIMEWIRE PRESTIGE PLUS2Cleared 510(K)
- K111498FATHOM (TM) 14 STEERABLE GUIDEWIRE2Cleared 510(K)
- K111488MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-60032Cleared 510(K)
- K111485FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX2Cleared 510(K)
- K103377CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-2832Cleared 510(K)
- K110479ACUITY WHISPER VIEW GUIDE WIRES2Cleared 510(K)
- K110553ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE2Cleared 510(K)
- K101985ASAHI GUIDE WIRE EXTENSION 165CM2Cleared 510(K)
- K110241ENDOLOGIX GUIDEWIRE2Cleared 510(K)
- K110163APPROACH PRO ST WIRE GUIDE2Cleared 510(K)
- K103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITE2Cleared 510(K)
- K110009ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE2Cleared 510(K)
- K102818MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE2Cleared 510(K)
- K103057ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE2Cleared 510(K)
- K094062PERCU-PRO GUIDEWIRE2Cleared 510(K)
- K101729NEOWIRE PTA/PTCA GUIDEWIRE2Cleared 510(K)
- K100578ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S2Cleared 510(K)
- K102211CRUISER 18 GUIDEWIRE2Cleared 510(K)
- K101339ARCHER SUPER STIFF GUIDEWIRES2Cleared 510(K)
- K101648HI-TORQUE WINN GUIDE WIRE FAMILY2Cleared 510(K)
- K101116HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH2Cleared 510(K)
- K100425HASKAL TORQUE DEVICE2Cleared 510(K)
- K101011HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL2Cleared 510(K)
- K100930PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J2Cleared 510(K)
- K100093VSI TORQUE DEVICE2Cleared 510(K)
- K100710ROLL-X GUIDEWIRE2Cleared 510(K)
- K100470GTX 12 GIDEWIRE2Cleared 510(K)
- K100351NEUROSCOUT STEERABLE GUIDEWIRE2Cleared 510(K)
- K092965TRAILRUNNER GUIDEWIRES2Cleared 510(K)
- K093647TRAXCESS DOCKING WIRE2Cleared 510(K)
- K0935153 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON2Cleared 510(K)
- K093822DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY2Cleared 510(K)
- K093681MERIDIAN GUIDEWIRE2Cleared 510(K)
- K093397TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE2Cleared 510(K)
- K091582GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 152Cleared 510(K)
- K092303MERIT LAUREATE HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K091825HI-TORQUE PROGRESS GUIDE WIRE FAMILY2Cleared 510(K)
- K090193CONDUCTOR CORONARY GUIDEWIRE2Cleared 510(K)
- K091385APPROACH HYDRO ST WIRE GUIDE, MODEL HMW2Cleared 510(K)
- K083094STREAMER POLYMER GUIDEWIRE2Cleared 510(K)
- K090554ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE2Cleared 510(K)
- K081775THE MEDCOMP .010 VASCULAR GUIDEWIRES2Cleared 510(K)
- K083738HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 052Cleared 510(K)
- K090274MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE2Cleared 510(K)
- K083732TAD AND TAD II TAPERED GUIDE WIRES2Cleared 510(K)
- K083713.035 LOC GUIDE WIRE EXTENSION2Cleared 510(K)
- K083727STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-30122Cleared 510(K)
- K083706HI-TORQUE VERSACORE GUIDE WIRE2Cleared 510(K)
- K082873MEDTRONIC ANGIOGRAPHIC GUIDE WIRES2Cleared 510(K)
- K083904ASAHI SUOH PTCA GUIDE WIRE2Cleared 510(K)
- K083145ASAHI GUIDE WIRE EXTENSION, MODEL AG1490002Cleared 510(K)
- K082094BARD PTFE (TEFLON) COATED GUIDE WIRES2Cleared 510(K)
- K082922FREEWAY AND RAILRUNNER GUIDEWIRES2Cleared 510(K)
- K082935VISION WIRE CORONARY GUIDEWIRE2Cleared 510(K)
- K083146ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 14030002Cleared 510(K)
- K081187BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-30012Cleared 510(K)
- K082304ROLL-X GUIDEWIRE2Cleared 510(K)
- K080637POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS2Cleared 510(K)
- K080364FINDRWIRZ GUIDE WIRE SYSTEM2Cleared 510(K)
- K081337APPROACH CTO WIRE GUIDE2Cleared 510(K)
- K081021KINETIX GUIDEWIRE, PLUS GUIDEWIRE2Cleared 510(K)
- K080765CROSSER LP SYSTEM2Cleared 510(K)
- K080863TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K072460HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE2Cleared 510(K)
- K080563RUNTHROUGH NS EXTENSION WIRE2Cleared 510(K)
- K080144MANDREL GUIDEWIRES OR M-WIRES2Cleared 510(K)
- K073162SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING2Cleared 510(K)
- K073655PEGASUS STEERABLE (PTCA) GUIDEWIRE2Cleared 510(K)
- K073082CPS COURIER GUIDEWIRE2Cleared 510(K)
- K070945ASAHI PTCA GUIDE WIRE2Cleared 510(K)
- K072552MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE2Cleared 510(K)
- K072705ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J2Cleared 510(K)
- K070212CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)2Cleared 510(K)
- K072431ASAHI PTCA GUIDE WIRE, X-TREME2Cleared 510(K)
- K071029CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)2Cleared 510(K)
- K071721ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M3712Cleared 510(K)
- K062192OSTIAL PRO STENT POSITIONING SYSTEM2Cleared 510(K)
- K070410COOK MICROWIRE WIRE GUIDE2Cleared 510(K)
- K063695RUNTHROUGH NS2Cleared 510(K)
- K063210ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR4194882Cleared 510(K)
- K070150VASCUPUNCTURE PICC GUIDEWIRE2Cleared 510(K)
- K063819ASAHI PTCA GUIDE WIRE, FIELDER FC2Cleared 510(K)
- K063372RADIFOCUS GLIDEWIRE ADVANTAGE2Cleared 510(K)
- K061670LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE2Cleared 510(K)
- K062186ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J2Cleared 510(K)
- K061984TREASURE2Cleared 510(K)
- K061453HI-TORQUE WHISPER VIEW GUIDE WIRE2Cleared 510(K)
- K060551BRIVANT GUIDEWIRE2Cleared 510(K)
- K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX2Cleared 510(K)
- K060449HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE2Cleared 510(K)
- K053265MICRUS GUIDE WIRE, WATUSI 0.0142Cleared 510(K)
- K053187AMPLATZER NOODLEWIRE GUIDEWIRE2Cleared 510(K)
- K060454TITAN GUIDEWIRE2Cleared 510(K)
- K053268PVS 2000 SYNCHRO2 GUIDEWIRE2Cleared 510(K)
- K053251TECHDEVICE GUIDEWIRE2Cleared 510(K)
- K052347TITAN STEERABLE (PTCA) GUIDEWIRE2Cleared 510(K)
- K052339ASAHI PTCA GUIDE WIRE2Cleared 510(K)
- K052783MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX2Cleared 510(K)
- K052022ASAHI PTCA GUIDE WIRE FIELDER2Cleared 510(K)
- K051062VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO2Cleared 510(K)
- K051374CARDIODRIVE CATHETER ADVANCEMENT SYSTEM2Cleared 510(K)
- K050964PV 1900 SYNCHRO 0.016 GUIDEWIRE2Cleared 510(K)
- K050915SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]2Cleared 510(K)
- K050873CANALIZER HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K050756SKIPPER AND SKIPPER RACE GUIDEWIRE2Cleared 510(K)
- K042373GALEO FOCUS GUIDE WIRE2Cleared 510(K)
- K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE2Cleared 510(K)
- K043457MODIFICATION TO ENDOVASCULAR GUIDE WIRE2Cleared 510(K)
- K042854STEREOTAXIS ENDOVASCULAR GUIDE WIRE2Cleared 510(K)
- K043422ASAHI PTCA GUIDE WIRE, J SHAPE SERIES2Cleared 510(K)
- K042370TORAYGUIDE GUIDEWIRE2Cleared 510(K)
- K040592CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE2Cleared 510(K)
- K042996COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE2Cleared 510(K)
- K042264GUIDEWIRES2Cleared 510(K)
- K042611LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE2Cleared 510(K)
- K041740SILICONE COATED GUIDEWIRE2Cleared 510(K)
- K042338CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE2Cleared 510(K)
- K041973MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K041762FINISHING WIRE SUPPORTRAK2Cleared 510(K)
- K041531ASAHI PTCA GUIDE WIRE CONFIANZA PRO2Cleared 510(K)
- K041624PTCA STEERABLE HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K040825LAKE REGION HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K040867PERIVAC KIT, MODELS 4304, 4305, 4314, 43152Cleared 510(K)
- K040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING2Cleared 510(K)
- K040037MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K040345MODIFICATION TO NITREX NITINOL GUIDEWIRE2Cleared 510(K)
- K040100ARROW ECHOGENIC INTRODUCER NEEDLE2Cleared 510(K)
- K040140IQ GUIDE WIRE2Cleared 510(K)
- K033929MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K033742BOSTON SCIENTIFIC V-18 CONTROL WIRE2Cleared 510(K)
- K032031SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K033758HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K033708MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K033542EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE2Cleared 510(K)
- K033321SELECTIVA SB GUIDEWIRE2Cleared 510(K)
- K032899RADIUS COUGAR WIRE2Cleared 510(K)
- K032411JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE2Cleared 510(K)
- K031652VASCUPUNCTURE PICC GUIDEWIRE2Cleared 510(K)
- K032615ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH1473002Cleared 510(K)
- K031678HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K031442PBN GUIDEWIRES2Cleared 510(K)
- K032146PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES2Cleared 510(K)
- K032050PERIVAC KIT2Cleared 510(K)
- K032183IQ HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K032129RADIUS 018 COUGAR WIRE2Cleared 510(K)
- K031916GALT MEDICAL GUIDEWIRE2Cleared 510(K)
- K031864NITREX NITINOL GUIDEWIRE2Cleared 510(K)
- K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE2Cleared 510(K)
- K031277JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,1410022Cleared 510(K)
- K030549HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG2Cleared 510(K)
- K022813STEERABLE GUIDEWIRE2Cleared 510(K)
- K030019MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE2Cleared 510(K)
- K024021NITREX NITINOL GUIDEWIRE2Cleared 510(K)
- K022762JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M0502Cleared 510(K)
- K023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE2Cleared 510(K)
- K021363ENDOVASCULAR GUIDE WIRE2Cleared 510(K)
- K023300HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J2Cleared 510(K)
- K022357TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-8152Cleared 510(K)
- K021638ILT ADVANCING MECHANISM, MODEL A115AMI2Cleared 510(K)
- K021990GALT MEDICAL GUIDEWIRE2Cleared 510(K)
- K021243ILT TORQUER, MODEL 114TR12Cleared 510(K)
- K020821SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 1172Cleared 510(K)
- K021323MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM2Cleared 510(K)
- K021219SMARTWIRE/SMARTMAP PRESSURE SYSTEM2Cleared 510(K)
- K021228HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE2Cleared 510(K)
- K021285HI-TORQUE EXTRA S'PORT GUIDEWIRE2Cleared 510(K)
- K011986SAFE-STEER GUIDE WIRE SYSTEM2Cleared 510(K)
- K014075BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/1452Cleared 510(K)
- K020340MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K020283BACK-UP MEIER STEERABLE GUIDEWIRE2Cleared 510(K)
- K012861VASCUPUNCTURE ACCESS WIRE2Cleared 510(K)
- K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K013833HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 100962Cleared 510(K)
- K013092HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K013024SELECTIVA GUIDEWIRE2Cleared 510(K)
- K011905SNIPER ELITE MODEL-OR-E3872XX SERIES2Cleared 510(K)
- K011906BACK-UP MEIER GUIDEWIRE2Cleared 510(K)
- K011968STREERABLE PTCA GUIDEWIRE2Cleared 510(K)
- K011287RADIUS COUGAR WIRE2Cleared 510(K)
- K003084CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 900122Cleared 510(K)
- K011084MANDREL GUIDEWIRE ASSEMBLY2Cleared 510(K)
- K010497SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-3002Cleared 510(K)
- K002907PVS 1300 NEURO GUIDE WIRE2Cleared 510(K)
- K010511MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES2Cleared 510(K)
- K003394APPALEAD GW+03XXXXXXR SERIES2Cleared 510(K)
- K003483MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)2Cleared 510(K)
- K003398WIRECLIP TORQUER2Cleared 510(K)
- K002707PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING2Cleared 510(K)
- K002962PRESSURE WIRE SENSOR, MODEL 12003/123032Cleared 510(K)
- K002289INQWIRE DIAGNOSTIC GUIDE WIRE2Cleared 510(K)
- K002346WIRE, GUIDE, CATHETER, MODEL QSW10002Cleared 510(K)
- K002206HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO2Cleared 510(K)
- K002212MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-06082Cleared 510(K)
- K001736GALEO HYDRO AND GALEO HYDRO J-TIP2Cleared 510(K)
- K001251SNIPER, MODEL OR-3872XX SERIES2Cleared 510(K)
- K001454SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D2Cleared 510(K)
- K001198DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET2Cleared 510(K)
- K001033AGILITY STEERABLE GUIDEWIRE2Cleared 510(K)
- K000011MODIFIED HYDROPHILIC COATED GUIDEWIRE2Cleared 510(K)
- K981936ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION2Cleared 510(K)
- K994358ATW MARKER WIRE STEERABLE GUIDEWIRE2Cleared 510(K)
- K993000BARD HYDROPHILIC COATED GUIDE WIRES2Cleared 510(K)
- K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE2Cleared 510(K)
- K993257.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI2Cleared 510(K)
- K991646AGILITY STEERABLE GUIDEWIRE2Cleared 510(K)
- K992237MEDTRONIC GT2 FUSION GUIDE WIRES2Cleared 510(K)
- K990271ENDOSONICS TRAK BACK DEVICE2Cleared 510(K)
- K990823PVS 1400 GUIDEWIRE2Cleared 510(K)
- K991898ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE2Cleared 510(K)
- K991194MODIFICATION TO ULTRA-SELECT GUIDEWIRE2Cleared 510(K)
- K991152HI-TORQUE BALANCE TREK GUIDE WIRE2Cleared 510(K)
- K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.2Cleared 510(K)
- K983346STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF2Cleared 510(K)
- K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING2Cleared 510(K)
- K983506PRESSUREWIRE SENSOR, MODEL #120012Cleared 510(K)
- K982559GUIDEWIRE2Cleared 510(K)
- K982272GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 0182Cleared 510(K)
- K982543SILVERSTREAK HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K983771STRATEGY CORONARY WIRE GUIDE2Cleared 510(K)
- K974241SCIMED INFORMER PRESSURE WIRE SYSTEM2Cleared 510(K)
- K983033ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE2Cleared 510(K)
- K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 10032822Cleared 510(K)
- K980977PIOLAX HYDROPHILIC GUIDEWIRE2Cleared 510(K)
- K982592DOCKING-EXTENSION WIRE2Cleared 510(K)
- K974713BARD HYDROPHILLIC COATED GUIDE WIRE2Cleared 510(K)
- K982083ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K971322CORE AND COIL ASSEMBLY GUIDEWIRE2Cleared 510(K)
- K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,12Cleared 510(K)
- K981326LAKE REGION MANUFACTURING GUIDEWIRES2Cleared 510(K)
- K974560CORDIS VANGUARD STEERABLE GUIDEWIRES2Cleared 510(K)
- K980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES2Cleared 510(K)
- K980294ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING2Cleared 510(K)
- K972793PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE2Cleared 510(K)
- K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE2Cleared 510(K)
- K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC2Cleared 510(K)
- K973945LUGE GUIDE WIRE2Cleared 510(K)
- K973845CORDIS HYDRONOL STEERABLE GUIDEWIRE2Cleared 510(K)
- K973708TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL2Cleared 510(K)
- K971086RADIAL AND FEMORAL ARTERY CATHETER2Cleared 510(K)
- K973494HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG2Cleared 510(K)
- K971688IVT 0.014 PTFE-COATED TRACKWIRE2Cleared 510(K)
- K970938HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING2Cleared 510(K)
- K972944MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT2Cleared 510(K)
- K971719THEROX INFUSION GUIDEWIRES2Cleared 510(K)
- K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES2Cleared 510(K)
- K971281RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE2Cleared 510(K)
- K972290ACS HI-TORQUE RULER GUIDE WIRE2Cleared 510(K)
- K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING2Cleared 510(K)
- K965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM2Cleared 510(K)
- K971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE2Cleared 510(K)
- K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIRE2Cleared 510(K)
- K971254TRANSEND EX PLATINUM GUIDEWIRE2Cleared 510(K)
- K970528CLYDE CORONARY GUIDEWIRE2Cleared 510(K)
- K970376PTCA GUIDEWIRE2Cleared 510(K)
- K964551CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID2Cleared 510(K)
- K970690LOCKING STYLET 22Cleared 510(K)
- K970494HANNIBAL GUIDEWIRE2Cleared 510(K)
- K970244SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES2Cleared 510(K)
- K965023CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE2Cleared 510(K)
- K962765CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)2Cleared 510(K)
- K964611TRANSEND GUIDEWIRE2Cleared 510(K)
- K964352TORQUE DEVICE2Cleared 510(K)
- K963702ACS HI-TORQUE IRON MAN GUIDE WIRE2Cleared 510(K)
- K962572SCIMED CHOICE PT VISION PTCA GUIDE WIRE2Cleared 510(K)
- K954642HYDRO-SELECT GUIDEWIRE2Cleared 510(K)
- K963320TFX MEDICAL GUIDEWIRE2Cleared 510(K)
- K961917MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)2Cleared 510(K)
- K963214CORDIS ST STEERABLE GUIDEWIRE2Cleared 510(K)
- K963171CINCH QR SGW EXTENSION2Cleared 510(K)
- K962932CORDIS STABILIZER PLUS XS2Cleared 510(K)
- K961107B. BRAUN GUIDEWIRES2Cleared 510(K)
- K9622660.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING2Cleared 510(K)
- K961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 24042Cleared 510(K)
- K961445RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL2Cleared 510(K)
- K961271USCI COMMANDER SERIES GUIDE WIRES2Cleared 510(K)
- K9612320.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP2Cleared 510(K)
- K960755CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS2Cleared 510(K)
- K960718LRM2Cleared 510(K)
- K955304CRICKET2Cleared 510(K)
- K961015SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE2Cleared 510(K)
- K960657SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE2Cleared 510(K)
- K960563SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES2Cleared 510(K)
- K954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK2Cleared 510(K)
- K954552RAILWIRE2Cleared 510(K)
- K9551350.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING2Cleared 510(K)
- K955175ACS ANCHOR EXCHANGE DEVICE2Cleared 510(K)
- K955637ESSENCE GUIDEWIRE2Cleared 510(K)
- K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 14042Cleared 510(K)
- K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD2Cleared 510(K)
- K943896GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS2Cleared 510(K)
- K952860THE NINER NITINOL GUIDEWIRE2Cleared 510(K)
- K935998ENTERPRISE2Cleared 510(K)
- K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)2Cleared 510(K)
- K953760CORDIS WIZDOM STEERABLE GUIDEWIRE2Cleared 510(K)
- K953533RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL2Cleared 510(K)
- K953023PRECEDER GUIDEWIRE2Cleared 510(K)
- K952562CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE2Cleared 510(K)
- K952430FINESSE GUIDEWIRE CORONARY2Cleared 510(K)
- K952067CORDIS STEERABLE GUIDEWIRE2Cleared 510(K)
- K945934URESIL(R) GUIDEWIRE2Cleared 510(K)
- K943390FLEXFINDER GUIDEWIRE2Cleared 510(K)
- K951307BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES2Cleared 510(K)
- K950216SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE2Cleared 510(K)
- K951109C-THRU CORONARY GUIDE WIRE2Cleared 510(K)
- K945379PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING2Cleared 510(K)
- K943358NAVIGUIDE HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K950835SCIMED CHOICE PT PTCA GUIDE WIRE2Cleared 510(K)
- K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS2Cleared 510(K)
- K950535SCIMED SCEPTOR EXCHANGE GUIDE WIRE2Cleared 510(K)
- K950534SCIMED SCEPTOR PTCA GUIDE WIRE2Cleared 510(K)
- K950352PRECEDER GUIDEWIRE2Cleared 510(K)
- K950316CORDIS STEERABLE GUIDEWIRES2Cleared 510(K)
- K950266SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE2Cleared 510(K)
- K950069DASHER-142Cleared 510(K)
- K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE2Cleared 510(K)
- K950141SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE2Cleared 510(K)
- K950113SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE2Cleared 510(K)
- K946356M-PATH NITINOL GUIDEWIRE2Cleared 510(K)
- K946240SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE2Cleared 510(K)
- K946180SCIMED(R) ENTRE PTCA GUIDE WIRE2Cleared 510(K)
- K945129SCIMED CHIOCE PLUS PTCA GUIDE WIRE2Cleared 510(K)
- K946029ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT2Cleared 510(K)
- K944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES2Cleared 510(K)
- K945159SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE2Cleared 510(K)
- K943522THE PROMPT GUIDWIRE2Cleared 510(K)
- K942453GUIDE WIRE2Cleared 510(K)
- K943022CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE2Cleared 510(K)
- K943340CORDIS STEERABLE GUIDEWIRE2Cleared 510(K)
- K941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES2Cleared 510(K)
- K942333SCIMED EN TRE' III PTCA GUIDE WIRE2Cleared 510(K)
- K942382MS AMPLATZ EXTRA STIFF GUIDE WIRE2Cleared 510(K)
- K940984CARDIOMETRICS DUALFLOW SWITCH BOX2Cleared 510(K)
- K935232HYDROTORQUE GUIDE WIRE2Cleared 510(K)
- K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE2Cleared 510(K)
- K935997PLATINUM PLUS GUIDEWIRE2Cleared 510(K)
- K941485CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES2Cleared 510(K)
- K941895SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING2Cleared 510(K)
- K941229ONTRAC STEERABLE GUIDEWIRE2Cleared 510(K)
- K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS2Cleared 510(K)
- K936032TORQUE DEVICE2Cleared 510(K)
- K935905SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP2Cleared 510(K)
- K930982ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE2Cleared 510(K)
- K935577SCIMED ENTRE II PTCA GUIDE WIRE2Cleared 510(K)
- K933334MAGIC TORQUE GUIDEWIRE2Cleared 510(K)
- K935022SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION2Cleared 510(K)
- K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE2Cleared 510(K)
- K934339LOC GUIDE WIRE EXTENSION2Cleared 510(K)
- K934474PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE2Cleared 510(K)
- K933517AUTOMATIC PULL BACK DEVICE2Cleared 510(K)
- K934359SCIMED STRIKE STEERABLE GUIDE WIRE2Cleared 510(K)
- K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES2Cleared 510(K)
- K933466USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING2Cleared 510(K)
- K932801CARDIMA SEEKER AND STUBBIE GUIDEWIRES2Cleared 510(K)
- K925947B-D ARTERIAL BLOOD CONTAINMENT DEVICE2Cleared 510(K)
- K924558ARROW BLOOD CONTAINMENT DEVICE2Cleared 510(K)
- K924385NEW HYDROPHILIC COATING FOR WIRE GUIDES2Cleared 510(K)
- K931327PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE2Cleared 510(K)
- K930787LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT2Cleared 510(K)
- K931584SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.2Cleared 510(K)
- K931514SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY2Cleared 510(K)
- K931577SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI2Cleared 510(K)
- K925852TERUMO CORONARY GUIDE WIRE2Cleared 510(K)
- K931171DOC-TITE(TM) GUIDE WIRE EXTENSION2Cleared 510(K)
- K925979DUAL LUMEN L-CATH CATHETER SYSTEM2Cleared 510(K)
- K930961CATHETER GUIDEWIRE (PERIPHERAL USE)2Cleared 510(K)
- K925342MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE2Cleared 510(K)
- K930622AMPLATZ GUIDEWIRES2Cleared 510(K)
- K926457SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR2Cleared 510(K)
- K930091CORDIS REFLEX STEERABLE GUIDEWIRE2Cleared 510(K)
- K925074USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING2Cleared 510(K)
- K922060.25' ULTRA-SELECT GUIDEWIRE2Cleared 510(K)
- K925804SCHNEIDER HYDRO-SIL GUIDEWIRE2Cleared 510(K)
- K925833CORDIS STEERABLE GUIDEWIRE2Cleared 510(K)
- K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIRE2Cleared 510(K)
- K915554HI-TORQUE SPORT-T(TM) GUIDE WIRE2Cleared 510(K)
- K923696CORDIS VIERA GUIDEWIRE2Cleared 510(K)
- K922787ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION2Cleared 510(K)
- K922674NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE2Cleared 510(K)
- K920891ROADRUNNER(TM) WIRE GUIDE, MODIFICATION2Cleared 510(K)
- K922706SCIMED SIDELINER2Cleared 510(K)
- K922536TORQUE DEVICE2Cleared 510(K)
- K924987TAPER GUIDEWIRES2Cleared 510(K)
- K924202RADIFOCUS(R) (CATHETER) GUIDE WIRE2Cleared 510(K)
- K922912SEEKER LITE - 102Cleared 510(K)
- K924009INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE2Cleared 510(K)
- K923134CORDIS STEERABLE GUIDEWIRE2Cleared 510(K)
- K920824ROADRUNNER RLTF GUIDE WIRE2Cleared 510(K)
- K923240BAXTER SENSOR CORONARY GUIDEWIRE2Cleared 510(K)
- K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI2Cleared 510(K)
- K920884GUIDEWIRES, VARIOUS TYPES2Cleared 510(K)
- K922302JAGWIRE(TM) RECANALIZATION GUIDEWIRE2Cleared 510(K)
- K922410SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL2Cleared 510(K)
- K915723.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE2Cleared 510(K)
- K914194SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE2Cleared 510(K)
- K914986GUIDE WIRES, MODIFICATION2Cleared 510(K)
- K915496DESERET GUIDEWIRE INTRODUCER2Cleared 510(K)
- K914531STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES2Cleared 510(K)
- K915115GUIDER DASHER2Cleared 510(K)
- K915114GUIDE WIRE EXTENSION2Cleared 510(K)
- K914031GUIDER-222Cleared 510(K)
- K914030GUIDER, DASHER2Cleared 510(K)
- K914032NITINOL SEEKER(R) GUIDE WIRES2Cleared 510(K)
- K914828010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF2Cleared 510(K)
- K914581HEART TECHNOLOGY WIRECLIP2Cleared 510(K)
- K914863CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT2Cleared 510(K)
- K914138ONTRAC2Cleared 510(K)
- K912293REMOVE LABELING RESTRICT FROM GUIDE WIRES2Cleared 510(K)
- K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE2Cleared 510(K)
- K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE2Cleared 510(K)
- K913353VASCULAR GUIDE WIRE2Cleared 510(K)
- K913328.010 HI-TORQUE PLUS(TM) GUIDE WIRE2Cleared 510(K)
- K913178ACS VSW GUIDE WIRE2Cleared 510(K)
- K912798AMPLANTZ AND BENTSON GUIDEWIRES2Cleared 510(K)
- K912878OPEN ENDED GUIDEWIRE2Cleared 510(K)
- K912156SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE2Cleared 510(K)
- K911547MAGNUM-MEIER RECANALIZATION GUIDEWIRE2Cleared 510(K)
- K911460.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP2Cleared 510(K)
- K910969TORQUE DEVICE FOR A GUIDE WIRE2Cleared 510(K)
- K910280ULTRA-SELECT PTCA GUIDEWIRE2Cleared 510(K)
- K905423CORDIS REFLEX STEERABLE GUIDEWIRE2Cleared 510(K)
- K905548PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE2Cleared 510(K)
- K904582QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE2Cleared 510(K)
- K905639TORQUE HANDLE DEVICE FOR GUIDEWIRE2Cleared 510(K)
- K905581SILICONE COATED GUIDEWIRES2Cleared 510(K)
- K905502.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP2Cleared 510(K)
- K905432DATASCOPE INTERLOCK GUIDE WIRE EXTENSION2Cleared 510(K)
- K904477GUIDEWIRE2Cleared 510(K)
- K902612CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT2Cleared 510(K)
- K903923USCI(R) SILK (TM) GUIDE WIRE2Cleared 510(K)
- K901899ROADRUNNER WIRE GUIDE2Cleared 510(K)
- K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP2Cleared 510(K)
- K902207ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE2Cleared 510(K)
- K902153TEFLON COATED GUIDEWIRE2Cleared 510(K)
- K902152MOVABLE CORE GUIDEWIRE2Cleared 510(K)
- K901347DATASCOPE SLIDEWIRE(TM)2Cleared 510(K)
- K900386ACS ADVANCED CONCEPT GUIDE WIRE2Cleared 510(K)
- K901224INSITE STEERABLE GUIDEWIRE2Cleared 510(K)
- K895899FLEXMEDICS GUIDEWIRE .012 ONLY2Cleared 510(K)
- K897152CRAGG CONVERTIBLE WIRE2Cleared 510(K)
- K896379ACS GOLD SERIES ELASTINITE GUIDE WIRE2Cleared 510(K)
- K895903IVT 0.014 GUIDE WIRE2Cleared 510(K)
- K894940DATASCOPE STEERING HANDLE2Cleared 510(K)
- K894633CORDIS STEERABLE COATED GUIDEWIRE2Cleared 510(K)
- K894318DATASCOPE INTERLOCK GUIDE WIRE EXTENSION2Cleared 510(K)
- K893626FLEXMEDICS GUIDEWIRE2Cleared 510(K)
- K890959GUIDEWIRE2Cleared 510(K)
- K890404USCI PROBE LINX EXTENSION WIRE2Cleared 510(K)
- K884183BURRON TEFLON-COATED GUIDEWIRE2Cleared 510(K)
- K890807GUIDE WIRE INTRODUCER2Cleared 510(K)
- K890505USCI GREY/BLACK GUIDE WIRE2Cleared 510(K)
- K890207INTERVENTIONAL PRODUCTS - GUIDE WIRES2Cleared 510(K)
- K883880KATZEN THROMBOLYSIS GUIDEWIRE2Cleared 510(K)
- K882507ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.2Cleared 510(K)
- K884895ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE2Cleared 510(K)
- K884490INTRODUCER SAFETY SYRINGE2Cleared 510(K)
- K884647USCI ADJUSTABLE TIP GUIDE WIRE2Cleared 510(K)
- K884274BUCHBINDER MULTIFLEX GUIDEWIRE2Cleared 510(K)
- K884262ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE2Cleared 510(K)
- K884198TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE2Cleared 510(K)
- K883579CORONARY GUIDE WIRE2Cleared 510(K)
- K8828040.014 PERIPHERAL GUIDE WIRE2Cleared 510(K)
- K882928TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE2Cleared 510(K)
- K880288TRU-TRAC TORQUE GUIDEWIRE2Cleared 510(K)
- K880287TRU-TRAC COILED GUIDEWIRE2Cleared 510(K)
- K882321ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT2Cleared 510(K)
- K880761TAPER-22 STEERABLE GUIDEWIRE2Cleared 510(K)
- K880762TAPER FLEX-TIP STEERABLE GUIDEWIRE2Cleared 510(K)
- K880722COATING FOR WIRE GUIDE2Cleared 510(K)
- K881897ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW2Cleared 510(K)
- K880332MEDRAD OPEN ENDED GUIDEWIRE2Cleared 510(K)
- K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE2Cleared 510(K)
- K880927VASCU-CARE ANGIOSCOPE2Cleared 510(K)
- K874202ACS HI-TORQUE GUIDE WIRES2Cleared 510(K)
- K873972GUIDE WIRE INTRODUCER2Cleared 510(K)
- K875323MODIFIED SCHNEIDER-SHILEY WIRE TORQUER2Cleared 510(K)
- K873403CORDIS STEERABLE GUIDEWIRE2Cleared 510(K)
- K874542TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES2Cleared 510(K)
- K874776ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR2Cleared 510(K)
- K871850TELEFLEX STEERABLE GUIDEWIRE2Cleared 510(K)
- K873942GUIDE WIRE BOWL2Cleared 510(K)
- K865017ANGIOSCOPE2Cleared 510(K)
- K873543STUBBIE STEERABLE GUIDEWIRE2Cleared 510(K)
- K871517OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE2Cleared 510(K)
- K871882LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)2Cleared 510(K)
- K871492AIS ANGIOSCOPE2Cleared 510(K)
- K872220ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)2Cleared 510(K)
- K871137MINISTIK MINI PUNCTURE SET CATALOG CODE #575052Cleared 510(K)
- K870664GUIDE WIRE2Cleared 510(K)
- K864316TARGET THERAPEUTICS TAPER GUIDE WIRE2Cleared 510(K)
- K864787SCHNEIDER-SHILEY GUIDE WIRE2Cleared 510(K)
- K864058AMPLATZ MOVEABLE CORE GUIDEWIRE2Cleared 510(K)
- K864585ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH2Cleared 510(K)
- K863138TERUMO RADIFOCUS GUIDE WIRE2Cleared 510(K)
- K862937BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE2Cleared 510(K)
- K863178UMI STEERABLE TORQUE GUIDE WIRE2Cleared 510(K)
- K862983ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES2Cleared 510(K)
- K862360ACS HI-TORQUE FLEX-T GUIDE WIRE2Cleared 510(K)
- K862567ACS WIRE SHAPER2Cleared 510(K)
- K860430THE NAVIGATOR STEERABLE GUIDE WIRE2Cleared 510(K)
- K862409SNAP-ON TORQUER2Cleared 510(K)
- K861115TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE2Cleared 510(K)
- K862048SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM2Cleared 510(K)
- K861606SCHNEIDER-SHILEY WIRE TORQUER2Cleared 510(K)
- K861765ACS WHOLEY HI-TORQUE GUIDE WIRE2Cleared 510(K)
- K861574ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE2Cleared 510(K)
- K860258TELEFLEX TEFLON COATED GUIDEWIRE2Cleared 510(K)
- K860841GUIDE WIRE INTRODUCER2Cleared 510(K)
- K860840GUIDED WIRE TORQUER2Cleared 510(K)
- K854912ANGIOMED GUIED WIRES2Cleared 510(K)
- K860533(.O38) HI-TORQUE GUIDE WIRES2Cleared 510(K)
- K854830ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES2Cleared 510(K)
- K855089PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 505052Cleared 510(K)
- K854511ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET2Cleared 510(K)
- K853999GUIDE WIRE2Cleared 510(K)
- K850677TELEFLEX GUIDEWIRE2Cleared 510(K)
- K852354WHOLEY HI-TORQUE GUIDE WIRES2Cleared 510(K)
- K850828WIRE, GUIDE - MODIFICATION2Cleared 510(K)
- K850827GUIDE, WIRE, ANGIOGRAPHIC2Cleared 510(K)
- K852123WHOLEY HI-TORQUE GUIDE WIRES2Cleared 510(K)
- K851574MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T2Cleared 510(K)
- K840756BIOPATCH BOVINE PERICARDIAL PATCH2Cleared 510(K)
- K841926HYDROGLIDE SPRING GUIDE WIRES2Cleared 510(K)
- K843012WIREGUIDE OR GUIDEWIRE2Cleared 510(K)
- K840391ANGIOGRAPHIC PROCEDURE TRAY2Cleared 510(K)
- K841071PRESSURE MANOMETER2Cleared 510(K)
- K834223CARDIOVASCULAR SPRING GUIDE WIRE2Cleared 510(K)
- K834237GRADUATED GUIDE WIRE BOWL 82Cleared 510(K)
- K833574PERCUTANEOUS SHEATH INTRODUCER TRAYS2Cleared 510(K)
- K832607OPEN END SPRING GUIDE2Cleared 510(K)
- K831839STAINLESS STEEL GUIDE WIRE2Cleared 510(K)
- K822586TEFLON COATED GUIDE WIRES & CATHETER2Cleared 510(K)
- K822597GUIDE WIRE2Cleared 510(K)
- K821190GUIDE WIRE2Cleared 510(K)
- K820699CATHETER GUIDE WIRE2Cleared 510(K)
- K810675ARROW RADIAL ARTERY CATHETERIZATION SET2Cleared 510(K)
- K802473BENZALKONIUM-HEPARIN COATED GUIDEWIRES2Cleared 510(K)
- K802260VASCULAR CATHETER WIREGUIDES2Cleared 510(K)
- K791276PERVENOUS LEAD INTRODUCER SYSTEM2Cleared 510(K)
- K790882LEAD INTRODUCER SET2Cleared 510(K)
- K790258MOVABLE CORE SAFETY GUIDE2Cleared 510(K)
- K781561ANGIOGRAPHIC GUIDE WIRE2Cleared 510(K)
- K781393VARIABLE STIFFNESS WIRE GUIDE2Cleared 510(K)
- K780438SAFETY SPRING GUIDES, TEFLON COATED2Cleared 510(K)
- K780493ELECATH PLASTIC JACKETED GUIDEWIRE2Cleared 510(K)
- K772021TRC STAINLESS STEEL SAFETY SPRING GUIDES2Cleared 510(K)
- K771231ARTEOIAL LINE KIT2Cleared 510(K)
- K771230PERCUTANEOUS INTRODUCER SHEATH SET2Cleared 510(K)
- K770977CARDIOVASCULAR SPRING GUIDES2Cleared 510(K)
- K760944ANGIOGRAPHIC GUIDEWIRE2Cleared 510(K)
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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BNLE Access Guidewire
- Page Type
- Cleared 510(K)
- 510(k) Number
- K221390
- 510(k) Type
- Traditional
- Applicant
- Biomerics NLE
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/28/2023
- Days to Decision
- 350 days
- Submission Type
- Summary