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
- K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter2Cleared 510(K)
- K242420pNOVUS 21 Microcatheter2Cleared 510(K)
- K233268Impress Angiographic Catheter2Cleared 510(K)
- K233975Zoom 6F Insert Catheters2Cleared 510(K)
- K232536Soldier Microcatheter2Cleared 510(K)
- K232573INFINITI™ Ambi Angiographic Catheter2Cleared 510(K)
- K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter2Cleared 510(K)
- K231293Drakon™ and Sequre® Microcatheters2Cleared 510(K)
- K230411Dragonfly OpStar™ Imaging Catheter2Cleared 510(K)
- K221279pNOVUS 21 Microcatheter2Cleared 510(K)
- K213666NuCath Wedge Pressure Catheter2Cleared 510(K)
- K221470Langston dual lumen catheter2Cleared 510(K)
- K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands2Cleared 510(K)
- K211078Progreat Lambda2Cleared 510(K)
- K201929KDL Angiography Catheter2Cleared 510(K)
- K203487Drakon and Sequre Microcatheters2Cleared 510(K)
- K202797Drakon and Sequre Microcatheters2Cleared 510(K)
- K193647Superpipe Angiographic Catheter2Cleared 510(K)
- K192267ILUMIEN System with AptiVue Software version D.32Cleared 510(K)
- K192122Trevo Trak 21 Microcatheter2Cleared 510(K)
- K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.12Cleared 510(K)
- K190126Bendit2.7 Steerable Microcatheter2Cleared 510(K)
- K191608Impress Angiographic Catheter2Cleared 510(K)
- K181722Polyethylene Catheter2Cleared 510(K)
- K180846Arterial Pressure Monitoring Set/Tray2Cleared 510(K)
- K180792Arterial Pressure Monitoring Set/Tray2Cleared 510(K)
- K180286Polyethylene Catheter2Cleared 510(K)
- K180054Royal Flush Plus High-Flow Catheter2Cleared 510(K)
- K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters2Cleared 510(K)
- K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters2Cleared 510(K)
- K180677Surefire Spark Infusion System2Cleared 510(K)
- K172635High-Flo Silver Polyethylene Catheter2Cleared 510(K)
- K173430SeQure® NF and SeQure® Microcatheters2Cleared 510(K)
- K171264Royal Flush Catheter2Cleared 510(K)
- K170544Langston dual lumen catheter2Cleared 510(K)
- K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter2Cleared 510(K)
- K170223Progreat2Cleared 510(K)
- K162448White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter2Cleared 510(K)
- K171355Surefire Precision Infusion System2Cleared 510(K)
- K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters2Cleared 510(K)
- K170406Plato MICROCATH 27B Microcatheter2Cleared 510(K)
- K162789Foresight Intracardiac Echocardiology (ICE) System2Cleared 510(K)
- K160660Medline Waste Station2Cleared 510(K)
- K163141NAMIC ClearaCIL Contrast Injection Lines2Cleared 510(K)
- K161822Torcon NB Advantage Catheters2Cleared 510(K)
- K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak2Cleared 510(K)
- K160662Surefire Infusion System2Cleared 510(K)
- K153125IntraNovo Microcatheter2Cleared 510(K)
- K151126Foresight Intracardiac Echocardiography (ICE) System2Cleared 510(K)
- K152605Impulse Angiographic Catheter, Expo Angiographic Catheter2Cleared 510(K)
- K150232Radifocus Optitorque Angiographic Catheter2Cleared 510(K)
- K151724AngioDynamics Mariner Angiographic Catheters2Cleared 510(K)
- K143398Plato MICROCATH 27B Microcatheter2Cleared 510(K)
- K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters2Cleared 510(K)
- K142817IntraNovo 25 Microcatheter2Cleared 510(K)
- K140356SUMMED HIGH PRESSURE LINE2Cleared 510(K)
- K143588Surefire Infusion System 0212Cleared 510(K)
- K133130BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER2Cleared 510(K)
- K141453ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER2Cleared 510(K)
- K141769OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER2Cleared 510(K)
- K131770PRESSURE CONNECTING TUBE2Cleared 510(K)
- K131437MODIFIED CONCENTRIC MICROCATHETER2Cleared 510(K)
- K123818URSA ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K122937SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)2Cleared 510(K)
- K121694IMAGER II ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K120008MEDLINE HIGH PRESSURE INJECTION TUBING2Cleared 510(K)
- K120917HEADWAY DUO MICROCATHETER2Cleared 510(K)
- K121734PLATO MICROCATH 27 MICROCATHETER2Cleared 510(K)
- K121954NMI MICROCATHETER2Cleared 510(K)
- K113335HEARTRAIL III GUIDING CATHETER2Cleared 510(K)
- K113819MONGOOSE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K121677SUREFIRE HI-FLOW MICROCATHETER2Cleared 510(K)
- K120495IMPULSE AND EXPO ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K112452ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K120893IMAGER II ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K113260MODIFIED CONCENTIRC MICROCATHETER2Cleared 510(K)
- K113737SUREFIRE GUIDE SHEATH2Cleared 510(K)
- K113638NMI 2.8 MICROCATHETER2Cleared 510(K)
- K102633BIOTEQ ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K112124MICROCATHETER2Cleared 510(K)
- K111619MODIFIED CONCENTRIC MICROCATHETER2Cleared 510(K)
- K110643MERIT MARQUIS FLOW SWITCH2Cleared 510(K)
- K110459SUREFIRE INFUSION CATHETER SYSTEM2Cleared 510(K)
- K110103EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER2Cleared 510(K)
- K101625COHEN CROSSOVER CATHETER2Cleared 510(K)
- K101669THERMODILUTION CATHETER2Cleared 510(K)
- K101239VIEWFLEX PLUS ICE CATHETER2Cleared 510(K)
- K093004IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING2Cleared 510(K)
- K090427URSA ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K092118ANGIOGRAPHIC CATHETER, MODEL ANGIOS2Cleared 510(K)
- K083384THERMODILUTION CATHETER2Cleared 510(K)
- K092702MICRUS MICROCATHETER, MODEL COURIER 2702Cleared 510(K)
- K091780GUIDED MEASUREMENT CATHETER (GMC)2Cleared 510(K)
- K092372HEARTRAIL III GUIDING CATHETER2Cleared 510(K)
- K091961MODIFIED CONCENTRIC MICROCATHETER, MODEL 900472Cleared 510(K)
- K083922MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-002Cleared 510(K)
- K090276ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)2Cleared 510(K)
- K081846GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 79512Cleared 510(K)
- K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K073585INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 79052Cleared 510(K)
- K073200GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 55822Cleared 510(K)
- K072796MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 900442Cleared 510(K)
- K072526MICRUS COURIER ENZO MICROCATHETER 0.01902Cleared 510(K)
- K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS2Cleared 510(K)
- K070456MICRUS COURIER ENZO MICROCATHETER 0.0172Cleared 510(K)
- K063784DYE MANAGEMENT SYSTEM2Cleared 510(K)
- K070011IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER2Cleared 510(K)
- K062877TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 52302Cleared 510(K)
- K062627INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 79052Cleared 510(K)
- K063312MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 389422Cleared 510(K)
- K061733ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-1352Cleared 510(K)
- K061963MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-002Cleared 510(K)
- K060010NAUTIFLUX2Cleared 510(K)
- K061565LANGSTON DUAL LUMEN CATHETER2Cleared 510(K)
- K052908INTRAREDX NIR IMAGING SYSTEM, MODEL MC-52Cleared 510(K)
- K060116MICRUS COURIER MICROCATHETERS2Cleared 510(K)
- K060175ISIGHT IMAGING CATHETER, MODEL 389862Cleared 510(K)
- K052637THEROX INFUSION CATHETER, MODEL INCA-12Cleared 510(K)
- K053171MERIT IMPRESS DIAGNOSTIC CATHETER2Cleared 510(K)
- K052865HOSPIRA CATH LAB CONVENIENCE KITS2Cleared 510(K)
- K051561ASAHI ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K050863IMAGER II ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K051395LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER2Cleared 510(K)
- K050371MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K050684ATLANTIS PV2Cleared 510(K)
- K050168LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER2Cleared 510(K)
- K050577ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 390142Cleared 510(K)
- K042685METRICATH SYSTEM2Cleared 510(K)
- K041909VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)2Cleared 510(K)
- K041123RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG017032Cleared 510(K)
- K034043H-FLOW VALVE2Cleared 510(K)
- K040830PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS2Cleared 510(K)
- K041291RINSPIRATION SYSTEM2Cleared 510(K)
- K040776ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 359752Cleared 510(K)
- K032888CREATION NM DIAGNOSTIC CATHETERS2Cleared 510(K)
- K033583PROGREAT2Cleared 510(K)
- K031599CD LEYCOM PRESSURE/VOLUME CATHETERS2Cleared 510(K)
- K031485RINSPIRATION SYSTEM2Cleared 510(K)
- K032624MICRUS MICROCATHETER2Cleared 510(K)
- K032376ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K024000METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER2Cleared 510(K)
- K023591ULTRA HIGH PRESSURE INJECTOR LINES2Cleared 510(K)
- K022004CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-12Cleared 510(K)
- K024126CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT2Cleared 510(K)
- K023681RENEGADE STC 18 MICROCATHETER2Cleared 510(K)
- K022621BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K021283GUIDANT BALLOON CATHETER, SEVERAL MODELS2Cleared 510(K)
- K021015ACIST PLUS 4 ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K020890SPYGLASS 4 FR ANGIOGRAPHICY CATHETER2Cleared 510(K)
- K020316CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU2Cleared 510(K)
- K012983ACIST 4 FRENCH ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K014054EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL2Cleared 510(K)
- K020012MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER2Cleared 510(K)
- K012749BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 0006642Cleared 510(K)
- K011664IMAGER II ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K003288ORIGEN DUAL LUMEN CATHETER2Cleared 510(K)
- K003105BIOSPHERE MEDICAL INFUSION CATHETER2Cleared 510(K)
- K011217CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT2Cleared 510(K)
- K003086CONCENTRIC MICRO CATHETER, MODELS 90001 TO 900082Cleared 510(K)
- K003020CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER2Cleared 510(K)
- K010707ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 359752Cleared 510(K)
- K002254COOK PRESSURE MONITORING CATHETER2Cleared 510(K)
- K003938TRAK BACK II2Cleared 510(K)
- K003901ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K003902MULTITRACK ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K001578ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K0008254F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K002416GOLDEN-RULE SCALING CATHETER2Cleared 510(K)
- K000743BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C40202Cleared 510(K)
- K000820AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 857002Cleared 510(K)
- K000579TEMPO AQUA ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K000956MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS2Cleared 510(K)
- K000659MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT2Cleared 510(K)
- K993694MIKRO-TIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K990173PATHFINDER II ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K992631ACUNAV DIAGNOSTIC ULTRASOUND CATHETER2Cleared 510(K)
- K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS2Cleared 510(K)
- K992123SCIMED IMPULSE ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K992051RADIFOCUS OPTITORQUE2Cleared 510(K)
- K984627AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K992142SCIMED ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K991673CORDIS TEMPO ANGIOGRAPHY CATHETER2Cleared 510(K)
- K984258NEUROVASX SUB-MICROINFUSION CATHETER2Cleared 510(K)
- K980973MEDTRONIC ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K971616BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)2Cleared 510(K)
- K982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K974774ENVY GUIDING CATHETER2Cleared 510(K)
- K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER2Cleared 510(K)
- K982077SELECTOR DIAGNOSTIC CATHETER2Cleared 510(K)
- K981441HEART CATH TRAY, STERILE, DISPOSABLE2Cleared 510(K)
- K980575SITESEER ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K973401TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)2Cleared 510(K)
- K964210RETRIEVER II2Cleared 510(K)
- K963335HARMAC BALLOON WEDGE PRESSURE CATHETER2Cleared 510(K)
- K962829HARMAC BALLOON ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K965112MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS2Cleared 510(K)
- K9708545 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K970207MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K971607MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K9716464F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER2Cleared 510(K)
- K971034USCI MAINSTAY GUIDING CATHETER2Cleared 510(K)
- K970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K9640333F ANGIOPTIC ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K965249SPYGLASS ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K964859SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K964331ASC HIGH PRESSURE BRAIDED TUBES2Cleared 510(K)
- K963092MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K960056USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC2Cleared 510(K)
- K961499LAGUNA SOFTIP DIAGNOSTIC CATHETERS2Cleared 510(K)
- K962805SPYGLASS ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K9627594F NYLEX ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K960806TURBO TRACKER2Cleared 510(K)
- K9609751-4F INFINITI ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K960070NUMED ATRIOSEPTOSTOMY CATHETER2Cleared 510(K)
- K960801SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)2Cleared 510(K)
- K955485BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K955111MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K952984MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)2Cleared 510(K)
- K954423ANGIOPTIC ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K952773MIKRO-TIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K950398CATHETER, BALLOON TYPE2Cleared 510(K)
- K950440DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD2Cleared 510(K)
- K953114EVOLUTION MICROCATHETER2Cleared 510(K)
- K950882BRAUN SELECTIVE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K950910TRANSIT-2 INFUSION CATHETER2Cleared 510(K)
- K951720SCIMED EXPO ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K9429270.035 IN. WISE WIRE2Cleared 510(K)
- K950855ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K950909TRANSIT-2 INFUSION CATHETER2Cleared 510(K)
- K950731SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K944284CONTROL2Cleared 510(K)
- K935985DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION2Cleared 510(K)
- K941978HIGH PRESSURE TUBING2Cleared 510(K)
- K943192SCIMED CHOICE(TM) PTCA GUIDE WIRE2Cleared 510(K)
- K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K932141CARDIAC CATHETERIZATION KIT2Cleared 510(K)
- K942939CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM2Cleared 510(K)
- K942231MICROVIEW II/MICRORAIL II CATHETERS2Cleared 510(K)
- K936282TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)2Cleared 510(K)
- K931560CARDIAC CATHETERIZATION TRAY2Cleared 510(K)
- K922455EVERT-O-CATH CATHETER2Cleared 510(K)
- K942329HAND CONTROLLED SYRINGE2Cleared 510(K)
- K942482PRESSURE MONITORING EXTENSION2Cleared 510(K)
- K941254DYE MANAGEMENT SYSTEM2Cleared 510(K)
- K936260TRANSIT INFUSION CATHETER2Cleared 510(K)
- K935403WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD2Cleared 510(K)
- K934541SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION2Cleared 510(K)
- K935402ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD2Cleared 510(K)
- K934581SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K925813DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K935654SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH2Cleared 510(K)
- K931629CARAPACE ANGIOGRAPHY TRAYS2Cleared 510(K)
- K930081OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR2Cleared 510(K)
- K933700DYE MANAGEMENT SYSTEM2Cleared 510(K)
- K931479SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K931833MODIFIED LUER2Cleared 510(K)
- K932218CARDIAC CATH OR ANGIOGRAPHIC TRAYS2Cleared 510(K)
- K932420SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING2Cleared 510(K)
- K926243ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K932542SCIMED 6F ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K930694MEDI-DYNE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K932092USCI ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K930232CVIS INSIGHT IMAGING GUIDE CATHETER2Cleared 510(K)
- K925632BALT GUIDING CATHETER2Cleared 510(K)
- K924922CVIS INSIGHT IMAGING CATHETER2Cleared 510(K)
- K922891CORDIS 7 FRENCH THRULUMEN CATHETER2Cleared 510(K)
- K926003SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER2Cleared 510(K)
- K930311CVIS LONGVIEW2Cleared 510(K)
- K930479NYLEX CATHETERS2Cleared 510(K)
- K921649RETRIEVER 102Cleared 510(K)
- K922552MORSE(R) ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K922101ANGIOGRAPHIC CATHETER -- MODIFICATION2Cleared 510(K)
- K920873WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD2Cleared 510(K)
- K920870ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD2Cleared 510(K)
- K923699DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K922484COBE SAMPLING SITE2Cleared 510(K)
- K922105USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING2Cleared 510(K)
- K921845INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT2Cleared 510(K)
- K923480SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA2Cleared 510(K)
- K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH2Cleared 510(K)
- K921310CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K922254LUKENS 2-0 BRAIDED SILK SUTURES2Cleared 510(K)
- K920980USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT2Cleared 510(K)
- K912270POLYCATH #WMC-9002Cleared 510(K)
- K921879CBIS CATHETER PULL-BACK DEVICE2Cleared 510(K)
- K915351SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER2Cleared 510(K)
- K914299CARDIAC CATHERIZATION KIT2Cleared 510(K)
- K915498CORDIS ANGIOGRAPHIC DOPPLER CATHER2Cleared 510(K)
- K920407DESERET GUIDEWIRE INTRODUCER II2Cleared 510(K)
- K920408DESERET GUIDEWIRE INTRODUCER III2Cleared 510(K)
- K915836CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS2Cleared 510(K)
- K915414TERUMO ANGIOGTAPHIC CATHETER2Cleared 510(K)
- K915136ATRAUMATIC TIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K913094DISPOSABLE SLIDE VALVE MANIFOLD2Cleared 510(K)
- K911270LEOCOR GUIDING CATHETER2Cleared 510(K)
- K914199ANGIOGRAPHIC SOFT TIP CATHETER2Cleared 510(K)
- K914208MERIT DISPOSAL DEPOT(TM)2Cleared 510(K)
- K912532ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH2Cleared 510(K)
- K914067RETRIEVAL DEVICE2Cleared 510(K)
- K914009SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K914128CONNECTING SET2Cleared 510(K)
- K913871FLOSWITCH(R) HP2Cleared 510(K)
- K914312SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS2Cleared 510(K)
- K913682MERIT CUSTOM KIT2Cleared 510(K)
- K912477ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION2Cleared 510(K)
- K913397MEGA ANGIOGRAM KIT2Cleared 510(K)
- K914141CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER2Cleared 510(K)
- K911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIES2Cleared 510(K)
- K914007CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH2Cleared 510(K)
- K911957ACS RX SUPPORT CATHETER2Cleared 510(K)
- K913364SCIMED 7 FR. & 8 FR.2Cleared 510(K)
- K912076POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF2Cleared 510(K)
- K911605TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES2Cleared 510(K)
- K911560ZEPHYR INFUSION CATHETER2Cleared 510(K)
- K911703CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER2Cleared 510(K)
- K911367BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH2Cleared 510(K)
- K9109877FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE2Cleared 510(K)
- K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)2Cleared 510(K)
- K910378PRESSURE MONITORING EXTENSION LINE2Cleared 510(K)
- K910259SCHNEIDER MAGNARAIL PROBING CATHETER2Cleared 510(K)
- K904618CVIS INSIGHT IMAGING CATHETER2Cleared 510(K)
- K910208BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS2Cleared 510(K)
- K903848DIAGNOSTIC INTRASCULAR CATHETER2Cleared 510(K)
- K905715ACS ANGIOSCOPIC CATHETER2Cleared 510(K)
- K905625CVIS INSIGHT IMAGING CATHETER2Cleared 510(K)
- K905499SCIMD 7 FR. TRIGUIDE GUIDING CATHETER2Cleared 510(K)
- K905727USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K905297DIAVENTIONAL CATHETER2Cleared 510(K)
- K904491TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-0002Cleared 510(K)
- K905018LAB-SITE SAFETY NEEDLE2Cleared 510(K)
- K905017LAB-SITE2Cleared 510(K)
- K904959PSG HEMOSTATIC CONTROL VALVE2Cleared 510(K)
- K904788MEWISSEN CATHETER2Cleared 510(K)
- K903199HOLLOW LUMEN NEEDLE, PART NUMBER: MX9202Cleared 510(K)
- K892671WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K902771ARTERIAL BLOOD SAMPLING KIT2Cleared 510(K)
- K902943RSI FEMORAL GUIDING CATHETER2Cleared 510(K)
- K902953SOFTOUCH GUIDING CATHETER2Cleared 510(K)
- K900460MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K901691CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE2Cleared 510(K)
- K895437SCIMED CORONARY GUIDING CATHETER2Cleared 510(K)
- K895180USCI 7F LARGE LUMEN GUIDING CATHETER2Cleared 510(K)
- K894401BALLOON THERMODILUTION CATHETERS2Cleared 510(K)
- K895542SONICATH(TM) 5 F2Cleared 510(K)
- K896308CORDIS SHUTTLE CATHETER2Cleared 510(K)
- K897051MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH2Cleared 510(K)
- K896741SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.2Cleared 510(K)
- K896690MODIFIED ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K895146GUIDING CATHETER2Cleared 510(K)
- K885221MULTILUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K893877BIOCHEM 3100 OXIMETER2Cleared 510(K)
- K894168SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F2Cleared 510(K)
- K895268ARROW HANDS-OFF THERMO-PACE2Cleared 510(K)
- K893830HEMO-ALERT2Cleared 510(K)
- K891580INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING2Cleared 510(K)
- K890206E-Z-FLOW ANGIOGRAPHY CATHETERS2Cleared 510(K)
- K885348A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL2Cleared 510(K)
- K890420USCI 7F GUIDE CATHETER2Cleared 510(K)
- K884354IMAGER FLUSH CATHETERS2Cleared 510(K)
- K882658ANGIOSCOPE FOR PULMONARY ARTERY USE2Cleared 510(K)
- K884502USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER2Cleared 510(K)
- K884065CATH LAB MONITORING CATHETER2Cleared 510(K)
- K883651MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER2Cleared 510(K)
- K883051USCI SOFT-TIP ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K882655PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE2Cleared 510(K)
- K875127NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS2Cleared 510(K)
- K882796SLIP-COAT(TM) CATHETERS2Cleared 510(K)
- K875337HEPARIN COATED LUMINAL PACING CATHETER2Cleared 510(K)
- K880661FIBEROPTIC CATHETER2Cleared 510(K)
- K875325MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK2Cleared 510(K)
- K875326MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER2Cleared 510(K)
- K874815TARGET THERAPEUTICS STERILE PRODUCTS2Cleared 510(K)
- K874037ANGIO WASTE FLUIDS DUMP BAG2Cleared 510(K)
- K870700MICRO-GUIDE2Cleared 510(K)
- K873438USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER2Cleared 510(K)
- K873004GUIDING CATHETER2Cleared 510(K)
- K872248DOUBLE LUMEN CATHETER2Cleared 510(K)
- K871021GUIDING CATHETERS 9F JL42Cleared 510(K)
- K870419IVR-SP CUSTOM ANGIOGRAPHY TRAY2Cleared 510(K)
- K864943NUMED BALLOON WEDGE PRESSURE CATHETER2Cleared 510(K)
- K864940NUMED BALLOON ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K861241ANGIOTOPO CATHETER2Cleared 510(K)
- K852547CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON2Cleared 510(K)
- K864141CORDIS CONTRAST INJECTION LINES2Cleared 510(K)
- K863137TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K863337CORDIPAK CARDIAC CATHETERIZATION PACK2Cleared 510(K)
- K862673MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER2Cleared 510(K)
- K862466SCHNEIDER-SHILEY FLUSHING CATHETER2Cleared 510(K)
- K862464SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR2Cleared 510(K)
- K862244MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS2Cleared 510(K)
- K862465SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK2Cleared 510(K)
- K862030POLY-TECH ANGIOGRAPHY CATHETER2Cleared 510(K)
- K854910ANGIOFLOW2Cleared 510(K)
- K861236ACS CORONARY GUIDING CATHETER2Cleared 510(K)
- K860867DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS2Cleared 510(K)
- K862006STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH2Cleared 510(K)
- K861483ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)2Cleared 510(K)
- K860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP53372Cleared 510(K)
- K860429MEADOX SURGIMED GUIDE CATHETER2Cleared 510(K)
- K860580ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP2Cleared 510(K)
- K854576MODIFIED CORDIS PTCA GUIDING CATHETERS2Cleared 510(K)
- K855103CIRIBART GYUDUBG CATGETER2Cleared 510(K)
- K854018ANGIOGRAPHY CATHETERS2Cleared 510(K)
- K853182DIAGNOSTIC INTRAVASCULAR CATHETERS2Cleared 510(K)
- K852197LAP-CATH2Cleared 510(K)
- K852456FAP-CATH2Cleared 510(K)
- K852872ANGIOMEDICS SOFTIP CATHETER2Cleared 510(K)
- K844854OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT2Cleared 510(K)
- K851088UMI ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K844800OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS2Cleared 510(K)
- K850271ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR2Cleared 510(K)
- K844555PATHFINDER CARDIOVASCULAR CATHETER2Cleared 510(K)
- K850341CARDIOVASCULAR SET UP2Cleared 510(K)
- K844598LARIAT CATHETER2Cleared 510(K)
- K844161PTCA GUIDING CATHER2Cleared 510(K)
- K843726NAMIC ADB ANGIOGRAPHIC DUMP BAG2Cleared 510(K)
- K842799PERCUTANEOUS ANGIOSCOPE DELIVERY CATH2Cleared 510(K)
- K842798INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH2Cleared 510(K)
- K842195ADVANCED CARDIOVASCULAR-CORONARY GUID2Cleared 510(K)
- K840763SILVERTORQUE CARDIAC CATHETERS2Cleared 510(K)
- K841615ELECATH HEPARIN-COATED CATHETERS2Cleared 510(K)
- K833554MATERIAL ADDITION LEXAN & K-RESIN2Cleared 510(K)
- K834459DIAGNOSTIC RADIOLOGY CATHETERS2Cleared 510(K)
- K834275SOFTIP CATHETER2Cleared 510(K)
- K832386PERCLUDER DL OCCLUDING BALLOON2Cleared 510(K)
- K831337COMPRESSAR DISPOSABLE DISC2Cleared 510(K)
- K831562SONTEK INFUSION CATHETER2Cleared 510(K)
- K831509ANGIOGRAPHY KIT W/ADDIT. COMPONENTS2Cleared 510(K)
- K831171DIGICATH2Cleared 510(K)
- K831189ANGIOGRAPHIC NEEDLE2Cleared 510(K)
- K830788CENTRAL VEIN CATHERIZATION KIT-14-690-2Cleared 510(K)
- K830415DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K830734FORGARTY BALLOON CALIBRATOR2Cleared 510(K)
- K830025DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-2Cleared 510(K)
- K830637VERTEX DIGITAL SUBSTRATION KIT2Cleared 510(K)
- K823754SAHOTA-KAPLAN HEMOSTAT2Cleared 510(K)
- K830576LYMPHANGIOGRAPHY SET2Cleared 510(K)
- K830523CATHETER CONNECTION W/INTEGRAL INJECTATE2Cleared 510(K)
- K823357VARIOUS CARDIOVASCULAR PRODUCTS2Cleared 510(K)
- K830420POLYETHYLENE MONITORING CONNECTORS2Cleared 510(K)
- K823758CENTRAL VEIN CATHERIZATION KIT2Cleared 510(K)
- K830237TRANSLUCENT POLY. CATH. CONNECTOR AND2Cleared 510(K)
- K823064INTRACATH-DA INTRAVENOUS CATH. PLACEMENT2Cleared 510(K)
- K830022S.M.P. CONTRAST MEDIA SET2Cleared 510(K)
- K823243SIDEARM Y-ADAPTOR2Cleared 510(K)
- K823065INTRA CATH-DSA INTRAVENOUS CATH PLACE.2Cleared 510(K)
- K822862BRACHIAL CORONARY GUIDING CATHETER2Cleared 510(K)
- K822640CORONARY INFUSION KIT2Cleared 510(K)
- K822594POLYETHYLENE CARDIOVASCULAR CATHETER2Cleared 510(K)
- K822598TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS2Cleared 510(K)
- K822596VERTEX PERCUTANEOUS PUNCTURE NEEDLE2Cleared 510(K)
- K822290STERILE PROTECTIVE SLEEVE W/TOUGH-BORST2Cleared 510(K)
- K822243GUIDING CATHETER2Cleared 510(K)
- K822100HIGH PRESSURE CONTRAST INJECTION LINE2Cleared 510(K)
- K822033BERMAN ANGIOGRAPHIC BALLOON CATHETER2Cleared 510(K)
- K821816ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K821976ANGIOGRAPHY KIT2Cleared 510(K)
- K820001CORONARY INFUSION KIT2Cleared 510(K)
- K813577PRESSURE INDICATOR-REGULATOR2Cleared 510(K)
- K813624ADVANCED CATHETER SYSTEMS CORONARY GUID2Cleared 510(K)
- K813622INDEFLATOR2Cleared 510(K)
- K813623SIMPSON-ROBERT CORONARY GUIDING CATHET2Cleared 510(K)
- K813140VYGON EXTENSION TUBES & CONNECTORS2Cleared 510(K)
- K813142LEADER-CATH2Cleared 510(K)
- K812999PET POLYETHYLENE TORQUE CATHETER2Cleared 510(K)
- K810508SONTEK ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K803270GANZ CORONARY REPERFUSION CATHETER2Cleared 510(K)
- K810360BAIM TM CORONARY SINUS FLOW THERMAL2Cleared 510(K)
- K810412USCI CARDIOVASCULAR CATHETER2Cleared 510(K)
- K802945PRESSURE MONITORING SET2Cleared 510(K)
- K802629STERI-SLEEVE2Cleared 510(K)
- K801322MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS2Cleared 510(K)
- K801321PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE2Cleared 510(K)
- K800622EXTENSION LINE2Cleared 510(K)
- K800618SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET2Cleared 510(K)
- K800741CENTRAL VEIN CATHETERIZATION KIT2Cleared 510(K)
- K800703MODIFIED CATHETER PACKAGE2Cleared 510(K)
- K800461CENTRAL VENOUS PRESSURE CATHETER2Cleared 510(K)
- K800171DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K791915WHITE SEALING CAP2Cleared 510(K)
- K790107CATHETER TUBING MODIFICATION2Cleared 510(K)
- K790082ARTERIAL EXTENSION SET2Cleared 510(K)
- K781819POST EXTRA SYSTOLIC POTENTIATOR2Cleared 510(K)
- K782082CATHETER, DIGITAL POSITRAL II2Cleared 510(K)
- K781558PRESSURE MONITORING INJECTION LINES2Cleared 510(K)
- K780529MYOCATH KIT2Cleared 510(K)
- K772175CATHETER SYSTEM, COPE/EISENBERG2Cleared 510(K)
- K771810PRESSURE TUBING2Cleared 510(K)
- K770868CATHETER, POLYURETHANE, W/STYLET2Cleared 510(K)
- K770290MONITORING KIT, CENTRAL VENOUS PRESSURE2Cleared 510(K)
- K770462PUNCTURE KIT, INTERNAL JUGULAR2Cleared 510(K)
- K760386CENTRAL VEINOUS PRESSURE SETS2Cleared 510(K)
- K760388CATHETER, VEIN (VENOFIX)2Cleared 510(K)
- K760387CATHETER, CAVA (CAVAFIX)2Cleared 510(K)
- K760402SYRINGE SET, 3-WAY THERMODILUTIN2Cleared 510(K)
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- 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
- 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
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HEMO-ALERT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K893830
- 510(k) Type
- Traditional
- Applicant
- KOREGON ENTERPRISE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/12/1989
- Days to Decision
- 141 days