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
- 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
- K244046Edwards eSheath Optima introducer set2Cleared 510(K)
- K250468iSLEEVE Introducer Set2Cleared 510(K)
- K243928ViaOne Epicardial Access System2Cleared 510(K)
- K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca2Cleared 510(K)
- K243493Agilis NxT Steerable Introducer Dual-Reach2Cleared 510(K)
- K242520Element Vascular Access System2Cleared 510(K)
- K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)2Cleared 510(K)
- K243061SonoStik Guide Wire Introducer2Cleared 510(K)
- K242106AuST Steerable Sheath2Cleared 510(K)
- K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/10082Cleared 510(K)
- K240600SafeCross Vascular Introducer System (4001)2Cleared 510(K)
- K242169Morph DNA Steerable Introducer Sheath2Cleared 510(K)
- K242248Introducer Sheath Kits2Cleared 510(K)
- K240957Catapult Guide Sheath2Cleared 510(K)
- K241708Abiomed 14Fr Low Profile Introducer Kit2Cleared 510(K)
- K241145TLAB® Transvenous Liver Biopsy System (TF-18C)2Cleared 510(K)
- K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)2Cleared 510(K)
- K240829AuST Steerable Sheath2Cleared 510(K)
- K240589Micropuncture Introducer Sets; Micropuncture Pedal Access Sets2Cleared 510(K)
- K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)2Cleared 510(K)
- K233959EPi-Ease Epicardial Access Device (EAS)2Cleared 510(K)
- K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer2Cleared 510(K)
- K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath2Cleared 510(K)
- K233691FlexCath Cross Transseptal Solution2Cleared 510(K)
- K233646Intri24 Introducer Sheath (52-101)2Cleared 510(K)
- K23343210F Sheath and Dilator Set2Cleared 510(K)
- K23350314F iSLEEVE Introducer Set2Cleared 510(K)
- K232260Thinline Sheath Introducer2Cleared 510(K)
- K231108Talon Transseptal Sheath2Cleared 510(K)
- K231828Pounce™ Sheath2Cleared 510(K)
- K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)2Cleared 510(K)
- K230631Kodiak™ Dual Port Coaxial Introducer Kit2Cleared 510(K)
- K230704RAIN Sheath™ Tibial Pedal Introducer2Cleared 510(K)
- K230283Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)2Cleared 510(K)
- K222184Introducer Sheath Kits2Cleared 510(K)
- K23005114F iSLEEVE™ Introducer Set2Cleared 510(K)
- K223872Low Profile Companion Sheath2Cleared 510(K)
- K221655Multiflex Steerable Sheath2Cleared 510(K)
- K222113Abiomed 14Fr Low Profile Introducer Set2Cleared 510(K)
- K222647INT Introducer Set2Cleared 510(K)
- K221914Catapult Guide Sheath2Cleared 510(K)
- K213582Epicardial Access System2Cleared 510(K)
- K221440Liverty™ TIPS Access Set2Cleared 510(K)
- K220414VersaCross Connect Transseptal Dilator2Cleared 510(K)
- K220604EXTesia Introducer Sheath Set2Cleared 510(K)
- K212392Intri24 Sheath2Cleared 510(K)
- K213492Dib UltraNav Transseptal Catheter System2Cleared 510(K)
- K212626PathBuilder Transseptal Guiding Introducer2Cleared 510(K)
- K220047AcQCross Qx Integrated Transseptal Dilator/Needle2Cleared 510(K)
- K211530PathBuilder Steerable Introducer2Cleared 510(K)
- K212152Prelude IDeal 9F Hydrophilic Sheath Introducer2Cleared 510(K)
- K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)2Cleared 510(K)
- K213002SCORPION Portal Vein Access Set2Cleared 510(K)
- K211405Prelude Guide Sheath2Cleared 510(K)
- K212708Halo One Thin-Walled Guiding Sheath2Cleared 510(K)
- K211989Aveir Introducer2Cleared 510(K)
- K210185CardioCurve Steerable Sheath2Cleared 510(K)
- K203459SafeCross Transseptal Puncture and Introducer (TSP/I) System2Cleared 510(K)
- K210627Breezeway II2Cleared 510(K)
- K210685AcQCross Qx Integrated Transseptal Dilator/Needle2Cleared 510(K)
- K202167Brite Tip Radianz Guiding Sheath2Cleared 510(K)
- K203670Extra Large Check-Flo Introducer2Cleared 510(K)
- K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set2Cleared 510(K)
- K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set2Cleared 510(K)
- K202226Lim Precision Steerable TS, Steerable Sheath, Dilator2Cleared 510(K)
- K202330Impella XR Sheath Set2Cleared 510(K)
- K203179Fortress Introducer Sheath System2Cleared 510(K)
- K202584iSleeve Introducer Set2Cleared 510(K)
- K201116Abiomed 23 Fr Sheath2Cleared 510(K)
- K200258Edwards eSheath Introducer Set2Cleared 510(K)
- K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX2Cleared 510(K)
- K193125R2P Destination Slender Guiding Sheath2Cleared 510(K)
- K192313Halo One Thin-Walled Guiding Sheath2Cleared 510(K)
- K193160Glidesheath Slender Tibial Pedal Kit2Cleared 510(K)
- K192769Impella CP Introducer2Cleared 510(K)
- K192106AcQRef Introducer Sheath2Cleared 510(K)
- K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set2Cleared 510(K)
- K191546Epicardial Access System2Cleared 510(K)
- K191190Steerable Introducer2Cleared 510(K)
- K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model2Cleared 510(K)
- K190628FlexSeal Introducer Sheath with Hydrophilic Coating2Cleared 510(K)
- K183655VersaCross Transseptal Sheath2Cleared 510(K)
- K190974D'Vill Introducer2Cleared 510(K)
- K190941BioCardia 8.5 F Avance Steerable lntroducer2Cleared 510(K)
- K190644Guide Sheath2Cleared 510(K)
- K190688VersaCross Steerable Sheath, VersaCross Transseptal Dilator2Cleared 510(K)
- K190369M-Y Sheath2Cleared 510(K)
- K181817transGlideXT Expandable Introducer2Cleared 510(K)
- K190184iSLEEVE Introducer Set2Cleared 510(K)
- K190098Endophys Pressure Sensing Sheath2Cleared 510(K)
- K181463DuraSheath Introducer Sheath System2Cleared 510(K)
- K181031TSI Transseptal Introducer2Cleared 510(K)
- K180620Endophys Pressure Sensing Sheath Kit2Cleared 510(K)
- K181088TSP Crosser Transseptal Access System2Cleared 510(K)
- K182243The CVC WAND Safety Introducer with Valved Peelable Sheath2Cleared 510(K)
- K180178Introducer Set2Cleared 510(K)
- K181592RAIN Sheath Transradial2Cleared 510(K)
- K181237Glidesheath Slender Tibial Pedal Kit2Cleared 510(K)
- K181855RadialSeal Introducer Kit2Cleared 510(K)
- K180785iSLEEVE Introducer Set2Cleared 510(K)
- K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access Set2Cleared 510(K)
- K180913VSI Micro-Introducer Kit2Cleared 510(K)
- K173831Glidesheath Slender2Cleared 510(K)
- K172980Micropuncture Pedal Access Set2Cleared 510(K)
- K180081RAILWAY Sheathless Access System2Cleared 510(K)
- K171988Performer Guiding Sheath2Cleared 510(K)
- K171820Transjugular Liver Access Sets2Cleared 510(K)
- K172331Type I, Type II, Type III, Type IV2Cleared 510(K)
- K173750Prelude IDeal Hydrophilic Sheath Introducer2Cleared 510(K)
- K171557AcQRef Introducer Sheath2Cleared 510(K)
- K173287Elite HV Radial2Cleared 510(K)
- K173685Peel-Away Introducer Set2Cleared 510(K)
- K171866Sentrant Introducer Sheath with Hydrophilic Coating2Cleared 510(K)
- K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design2Cleared 510(K)
- K173399Endophys Pressure Sensing Sheath Kit- 8F2Cleared 510(K)
- K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath2Cleared 510(K)
- K173068Performer Introducer2Cleared 510(K)
- K171206D'Vill Introducer2Cleared 510(K)
- K172099Shoocin Introducer Kit2Cleared 510(K)
- K171491R2P Destination Slender Guiding Sheath2Cleared 510(K)
- K170020Peel-Away Introducer Set2Cleared 510(K)
- K172117Prelude Pursuit Splittable Sheath Introducer2Cleared 510(K)
- K171853Liver Access and Biopsy Sets2Cleared 510(K)
- K171999Performer Introducer2Cleared 510(K)
- K170997CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath2Cleared 510(K)
- K170775Mini Stick ENVI Non-Vascular Introducer Kit2Cleared 510(K)
- K170695VenaCure EVLT NeverTouch Direct Introducer Sheath2Cleared 510(K)
- K171081Guider Catheter Introducer2Cleared 510(K)
- K170831EpiAccess System2Cleared 510(K)
- K170668HeartSpan Steerable Sheath Introducer2Cleared 510(K)
- K160721Vado Steerable Sheath2Cleared 510(K)
- K170373Flextra Steerable Introducer2Cleared 510(K)
- K163268FlexCath Select Steerable Shealth and Dilator2Cleared 510(K)
- K162427Vado Bi-Directional Steerable Sheath2Cleared 510(K)
- K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model2Cleared 510(K)
- K162097InTRAkit2Cleared 510(K)
- K162769Pinpoint GT Introducer Needle2Cleared 510(K)
- K153771TXM Guiding Sheath2Cleared 510(K)
- K162184Edwards eSheath Introducer Set2Cleared 510(K)
- K153494HQS Introducer (Model 2064-HQS)2Cleared 510(K)
- K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle2Cleared 510(K)
- K161659FlexSeal Introducer Sheath with Hydrophilic Coating2Cleared 510(K)
- K153533Tearaway Introducer Sheath, MicroSlide Tearaway Introducer2Cleared 510(K)
- K161183Halo One Thin-Walled Guiding Sheath2Cleared 510(K)
- K161102Nanostim Introducer Kit2Cleared 510(K)
- K160254GORE DrySeal Flex Introducer Sheath2Cleared 510(K)
- K160716The Nanostim Introducer Kit2Cleared 510(K)
- K152194transGlide Expandable Introducer2Cleared 510(K)
- K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select2Cleared 510(K)
- K160272Endophys Pressure Sensing Sheath Kit2Cleared 510(K)
- K153246PTFE Super Sheath Introducer 2.12Cleared 510(K)
- K153197Fortress Introducer Sheath SYstem2Cleared 510(K)
- K152498SoloPath Re-Collapsible Access System2Cleared 510(K)
- K151936Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle2Cleared 510(K)
- K152173Glidesheath2Cleared 510(K)
- K152225Edwards eSheath Introducer Set2Cleared 510(K)
- K152381Prelude SNAP Splittable Hydrophilic Sheath Introducer2Cleared 510(K)
- K152177SonoStik IV Guide Wire Introducer2Cleared 510(K)
- K151951Destino Reach2Cleared 510(K)
- K1521165.5 F Worley Advanced LVI Lateral Vein Introducer2Cleared 510(K)
- K152044Flexor Radial Hydrophilic Introducer Access Set2Cleared 510(K)
- K152054Confida Adaptive Sheath2Cleared 510(K)
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer2Cleared 510(K)
- K142819Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set2Cleared 510(K)
- K142357DuraSheath Introducer Sheath System2Cleared 510(K)
- K150257PreludeEASE Hydrophilic Sheath Introducer2Cleared 510(K)
- K150186Chariot Guiding Sheath2Cleared 510(K)
- K142445PINPOINT GT SAFETY INTRODUCER NEEDLE2Cleared 510(K)
- K143255Prelude SNAP Splittable Sheath Introducer2Cleared 510(K)
- K141275ENDOPHYS PRESSURE SENSING SHEATH KIT2Cleared 510(K)
- K141969FIRSTSTIC N INTRODUCER2Cleared 510(K)
- K140793NANOSTIM INTRODUCER KIT2Cleared 510(K)
- K140768TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT2Cleared 510(K)
- K142183GLIDESHEATH SLENDER2Cleared 510(K)
- K142684FlexCath Select Steerable Sheath (10 French)2Cleared 510(K)
- K142245EpiAccess System2Cleared 510(K)
- K140543PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER2Cleared 510(K)
- K132592FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET2Cleared 510(K)
- K141696EDWARDS ESHEATH INTRODUCER SET2Cleared 510(K)
- K140338CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)2Cleared 510(K)
- K140028GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER2Cleared 510(K)
- K140917INTRODUCER, MODEL ADELANTE MAGNUM2Cleared 510(K)
- K140513MERIT SAFETY INTRODUCER NEEDLE2Cleared 510(K)
- K140641VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA2Cleared 510(K)
- K133114MICROPUNCTURE INTRODUCER SET2Cleared 510(K)
- K140871AXERA 2 ACCESS SYSTEM2Cleared 510(K)
- K140287AXERA RX ACCESS SYSTEM2Cleared 510(K)
- K132617MEDTRONIC INPUT PS INTRODUCER2Cleared 510(K)
- K140406DESTINO TWIST, STEERABLE GUIDING SHEATH2Cleared 510(K)
- K132789FLIP INTRODUCER ACCESS KIT2Cleared 510(K)
- K140420VADO STEERABLE SHEATH2Cleared 510(K)
- K140201AXERA 2 ACCESS SYSTEM2Cleared 510(K)
- K140398EMBOL-X INTRODUCER SHEATH2Cleared 510(K)
- K140327ULTIMUM EV HEMOSTASIS INTRODUCER2Cleared 510(K)
- K131627CATHETER INTRODUCER SHEATH2Cleared 510(K)
- K133296XCATH2Cleared 510(K)
- K130633INTRODUCER SETS, MODEL ADELANTE RADIAL2Cleared 510(K)
- K132720HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH2Cleared 510(K)
- K140015CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER2Cleared 510(K)
- K123475SHOOCIN INTRODUCER KIT2Cleared 510(K)
- K132498VALVED TEARAWAY INTRODUCER GENERATION II2Cleared 510(K)
- K130730V-STICK VASCULAR ACCESS SET2Cleared 510(K)
- K132030MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING2Cleared 510(K)
- K132164HEARTSPAN STEERABLE INTRODUCER KIT2Cleared 510(K)
- K131148THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH2Cleared 510(K)
- K132263AXERA 2 ACCESS SYSTEM2Cleared 510(K)
- K131144AMECO SHEATH INTRODUCER2Cleared 510(K)
- K1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCER2Cleared 510(K)
- K131079CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC2Cleared 510(K)
- K130855PTFE SUPER SHEATH INTRODUCER2Cleared 510(K)
- K123714EDWARDS EMBOL-X INTRODUCER SHEATH2Cleared 510(K)
- K131332CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER2Cleared 510(K)
- K131300THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER2Cleared 510(K)
- K124046VALVED TEARAWAY INTRODUCER GENERATION II2Cleared 510(K)
- K130559MOBICATH BI-DIRECTIONAL GUIDING SHEATH2Cleared 510(K)
- K121404SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM2Cleared 510(K)
- K123990SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING2Cleared 510(K)
- K123430MICROSLIDER TEARAWAY INTRODUCER SET2Cleared 510(K)
- K123618AXERA 2 ACCESS SYSTEM2Cleared 510(K)
- K123974PERCUTANEOUS INTRODUCER KIT2Cleared 510(K)
- K123235EQUAFLOW MULTIVALVE INFUSION CATHETER2Cleared 510(K)
- K122431HEARTSPAN STEERABLE INTRODUCER KIT2Cleared 510(K)
- K123135AXERA 2 ACCESS SYSTEM MODEL AXE2002Cleared 510(K)
- K123334REPROCESSED STEERABLE INTRODUCER2Cleared 510(K)
- K122926SUREFLEX STEERABLE GUIDING SHEATH KIT2Cleared 510(K)
- K122854ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER2Cleared 510(K)
- K122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO2Cleared 510(K)
- K122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY2Cleared 510(K)
- K122980GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ2Cleared 510(K)
- K121234GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING2Cleared 510(K)
- K120617PTFE SUPER SHEATH INTRODUCER2Cleared 510(K)
- K121504SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS2Cleared 510(K)
- K122084INTRODUCER SET, MODEL ADELANTE-S SERIES2Cleared 510(K)
- K111603LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM2Cleared 510(K)
- K121185EDWARDS PERCUTANEOUS SHEATH INTRODUCER2Cleared 510(K)
- K122190PRELUDE 7F SHORT SHEATH INTRODUCER2Cleared 510(K)
- K120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS2Cleared 510(K)
- K113849HQS INTRODUCER2Cleared 510(K)
- K121748THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL2Cleared 510(K)
- K120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO2Cleared 510(K)
- K121521AXERA ACCESS SYSTEM2Cleared 510(K)
- K120428GORE DRYSEAL SHEATH2Cleared 510(K)
- K112398TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT2Cleared 510(K)
- K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR2Cleared 510(K)
- K120212AFX INTRODUCER SYSTEM2Cleared 510(K)
- K112407SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS2Cleared 510(K)
- K113196VASCULAR SONO2Cleared 510(K)
- K110051RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT2Cleared 510(K)
- K112554TRANSRADIAL ARTERY ACCESS DEVICES2Cleared 510(K)
- K102925NEXGEN EXPANDABLE CATHETER2Cleared 510(K)
- K113110AXERA ACCESS SYSTEM2Cleared 510(K)
- K111606PINNACLE PRECISION ACCESS SYSTEM2Cleared 510(K)
- K111943AGILLS PF DELIVERY SYSTEM2Cleared 510(K)
- K111417THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER2Cleared 510(K)
- K111747ENDOLOGIX AFX INTRODUCER SYSTEM2Cleared 510(K)
- K111138THE PICC WAND (R) PEELABLE SAFETY INTRODUCER2Cleared 510(K)
- K111092ENGAGE/ENGAGE TR INTRODUCERS2Cleared 510(K)
- K110090AFX INTRODUCER SYSTEM2Cleared 510(K)
- K110450AGILIS NXT STEERABLE INTRODUCER2Cleared 510(K)
- K103083AGILIS ES STEERABLE INTRODUCER2Cleared 510(K)
- K102948TORFLEX TRANSSEPTAL GUIDING SHEATH2Cleared 510(K)
- K101422THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER2Cleared 510(K)
- K100799FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 3588152Cleared 510(K)
- K103143ARSTASIS ONE LATCHWIRE ACCESS SYSTEM2Cleared 510(K)
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- K092014SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER2Cleared 510(K)
- K090394VALVED TEARWAY INTRODUCER2Cleared 510(K)
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- K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLE2Cleared 510(K)
- K081697THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 900062Cleared 510(K)
- K083083AGILIS NXT STEERABLE INTRODUCER2Cleared 510(K)
- K082847PINNACLE ROII INTRODUCER SHEATH2Cleared 510(K)
- K082063PRELUDE SHORT SHEATH INTRODUCER2Cleared 510(K)
- K082644GLIDESHEATH2Cleared 510(K)
- K081394PTFE INTERLOCK PEELABLE INTRODUCERS2Cleared 510(K)
- K082356GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE2Cleared 510(K)
- K081045DESTINATION RENAL GUIDING SHEATH2Cleared 510(K)
- K081046PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2Cleared 510(K)
- K081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)2Cleared 510(K)
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- K061363AGILIS NXT STEERABLE INTRODUCER2Cleared 510(K)
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- K053400ACUMEN SINGLE-LUMEN DELIVERY SHEATH2Cleared 510(K)
- K060519INTRODUCER ASSEMBLY WITH ROTATOR LOCK2Cleared 510(K)
- K060190SUPER SHEATH XL INTRODUCER SHEATH2Cleared 510(K)
- K051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER2Cleared 510(K)
- K052644SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER2Cleared 510(K)
- K051248VYGON MICRO-ACCESS SAFETY INTRODUCER KIT2Cleared 510(K)
- K052185DESTINATION CAROTID GUIDING SHEATH2Cleared 510(K)
- K051515MODIFIED ACUMEN SHEATH, MODEL TTW 10-652Cleared 510(K)
- K051601PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2Cleared 510(K)
- K051468INNER-LOCK INTRODUCER SHEATH2Cleared 510(K)
- K051096APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 4075822Cleared 510(K)
- K043084PREMERE DELIVERY SHEATH, MODEL PDS2Cleared 510(K)
- K050023SECURELOC; ADVANCINTRODUCER2Cleared 510(K)
- K042308SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S000192Cleared 510(K)
- K043438LARGE BORE SPLITTABLE INTRODUCER KIT2Cleared 510(K)
- K043525CATHETER INTRODUCER2Cleared 510(K)
- K050015MODIFIED ACUMEN SHEATH, MODEL TTWO7672Cleared 510(K)
- K042623AGILIS STEERABLE CATHETER INTRODUCER, MODEL 4083042Cleared 510(K)
- K042399MODIFICATION TO SHORT INTRODUCER SHEATH2Cleared 510(K)
- K041708ENPATH SAFETY INTRODUCER2Cleared 510(K)
- K042376ACUMEN SHEATH, MODEL TTW78072Cleared 510(K)
- K041506INTRAVASCULAR ACCESS INTRODUCER SHEATH2Cleared 510(K)
- K042036AIRGUARD VALVED INTRODUCER2Cleared 510(K)
- K040728ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT2Cleared 510(K)
- K040713MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM2Cleared 510(K)
- K040552MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 31302Cleared 510(K)
- K040029SAFETYNET GUIDEWIRE INTRODUCER2Cleared 510(K)
- K034025NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC2Cleared 510(K)
- K040150MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2Cleared 510(K)
- K033527INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER2Cleared 510(K)
- K034061MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH2Cleared 510(K)
- K033681GLIDESHEATH2Cleared 510(K)
- K031922CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W2Cleared 510(K)
- K032569SHORT INTRODUCER SHEATH2Cleared 510(K)
- K032404SELDINGER SAFETY NEEDLE INTRODUCER2Cleared 510(K)
- K030734PATHWAY ACCESS SHEATH CATHETER2Cleared 510(K)
- K032073GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE2Cleared 510(K)
- K031906APEEL CS CATHETER DELIVERY SYSTEM2Cleared 510(K)
- K030135SAFETY INTRODUCER NEEDLE2Cleared 510(K)
- K030944EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL2Cleared 510(K)
- K031583MODIFICATION TO IVS INTRODUCER SET, MODEL 10032Cleared 510(K)
- K023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM2Cleared 510(K)
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- K030905MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2Cleared 510(K)
- K030723IVS INTRODUCER SET, MODEL 10032Cleared 510(K)
- K022170INNER-LOCK LOCKING INTRODUCER SHEATHS2Cleared 510(K)
- K022634CO-AXIAL INTRODUCER NEEDLE2Cleared 510(K)
- K023447MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)2Cleared 510(K)
- K022513MEDCOMP VASCU-SHEATH INTRODUCER SET2Cleared 510(K)
- K020964NEICH NM ADVANCE CATHETER SHEATH INTRODUCER2Cleared 510(K)
- K022003TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-03052Cleared 510(K)
- K022689MODIFICATION TO MEDAMICUS AXIA RSN2Cleared 510(K)
- K021723SHEATH ADAPTER, MODEL SA-098472Cleared 510(K)
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- K020834BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I2Cleared 510(K)
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- K020563MEDAMICUS AXIA RSN2Cleared 510(K)
- K010128COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE2Cleared 510(K)
- K014052EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL2Cleared 510(K)
- K020090MODIFICATION TO TRANSSEPTAL INTRODUCER SET2Cleared 510(K)
- K003889ANCURE SHEATH MODEL # 40315, 40320, 403252Cleared 510(K)
- K012854RENAL GUIDING SHEATH2Cleared 510(K)
- K012812CAROTID GUIDING SHEATH2Cleared 510(K)
- K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT2Cleared 510(K)
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- K013029SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 4075152Cleared 510(K)
- K010913VYGON SPLIT CANNULA INTRODUCER2Cleared 510(K)
- K012922ULTRAFLEX EV HEMOSTASIS INTRODUCER2Cleared 510(K)
- K011790MICROCRUISER PLUS INTRODUCER SET2Cleared 510(K)
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- K011085GUIDEWIRE INTRODUCER SAFETY NEEDLE2Cleared 510(K)
- K004026BRAIDED GUIDING INTRODUCER2Cleared 510(K)
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- K002054X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-12Cleared 510(K)
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- K003729ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),2Cleared 510(K)
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- K992668INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)2Cleared 510(K)
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- K001139PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M2Cleared 510(K)
- K000824PERCUTANEOUS INTRODUCER, MODEL 10383-XXX2Cleared 510(K)
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- K990975IN-LINE HEMOSTASIS VALVE2Cleared 510(K)
- K994252INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE2Cleared 510(K)
- K991647TFX MEDICAL INTRODUCER KIT2Cleared 510(K)
- K992309INTRODUCER SHEATH, VESSEL DILATOR2Cleared 510(K)
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- K983039EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF2Cleared 510(K)
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- K984500CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB2Cleared 510(K)
- K981909BAXTER HEMOSTASIS VALVE INTRODUCERS2Cleared 510(K)
- K983023MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K982187FAST-CATH INTRA-CARDIAC INTRODUCER2Cleared 510(K)
- K980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)2Cleared 510(K)
- K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S2Cleared 510(K)
- K981782LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K980504EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET2Cleared 510(K)
- K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCER2Cleared 510(K)
- K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET2Cleared 510(K)
- K974448CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K973007DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM2Cleared 510(K)
- K972684INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM2Cleared 510(K)
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- K965167PERCUTANEOUS VENOUS INTRODUCER 102642Cleared 510(K)
- K971608CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCER2Cleared 510(K)
- K964814BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER2Cleared 510(K)
- K964034TRANSJUGULAR ACCESS SET2Cleared 510(K)
- K963886EVS2Cleared 510(K)
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- K962978CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM2Cleared 510(K)
- K961780HEMODIALYSIS INTRODUCER SET2Cleared 510(K)
- K962180CATH SEAL2Cleared 510(K)
- K962746CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT2Cleared 510(K)
- K961745BRAUN PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K961466PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K960445INPUT TUOHY-BORST LOCKING DEVICE2Cleared 510(K)
- K960625SPREADABLE SHEATH INTRODUCER SET2Cleared 510(K)
- K960200INTROSTAT LEAD INTRODUCER2Cleared 510(K)
- K961513PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET2Cleared 510(K)
- K961135INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)2Cleared 510(K)
- K960406BRAUN HEMOSTASIS INTRODUCERS2Cleared 510(K)
- K954906FIRST PICC INTRODUCER CATHETER2Cleared 510(K)
- K955820BRAUN HEMOSTASIS INTRODUCERS2Cleared 510(K)
- K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET2Cleared 510(K)
- K960310EPIC INTRODUCER SHEATH2Cleared 510(K)
- K954595CORDIS BRITE TIP SHEATH INTRODUCER2Cleared 510(K)
- K942977NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE2Cleared 510(K)
- K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS2Cleared 510(K)
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- K952828MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM2Cleared 510(K)
- K940092USCI INPUT INTRODUCER SET2Cleared 510(K)
- K950155RAPID-TRAK(TM) INTRODUCER SHEATH2Cleared 510(K)
- K951313MEDAMICUS PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K945524CORDIS INTRODUCING CATHETER2Cleared 510(K)
- K945616CORDIS AVANTI CATHETER SHEATH INTRODUCER2Cleared 510(K)
- K945396FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET2Cleared 510(K)
- K933522INTRODUCER NEEDLE (SEVERAL SIZES)2Cleared 510(K)
- K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-079032Cleared 510(K)
- K942191URESIL DILATOR2Cleared 510(K)
- K944107VIP PLUS PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K941428EXACTA PERCUTANEOUS INTRODUCER SHEATH2Cleared 510(K)
- K935077CATH-SEAL2Cleared 510(K)
- K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE2Cleared 510(K)
- K930808PROTECTOR INTRODUCER SHEATH2Cleared 510(K)
- K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE2Cleared 510(K)
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- K932370REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET2Cleared 510(K)
- K932323PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K931743BURRON CARDIOVASCULAR ANGESTAT(TM)2Cleared 510(K)
- K931489INTHERM RADIALLY EXPANDING DILATING INTRODUCER2Cleared 510(K)
- K931587MULTI-PORT Y INTRODUCER SET2Cleared 510(K)
- K931218INTROPEEL V2Cleared 510(K)
- K930801INTROPEEL2Cleared 510(K)
- K930194HEMOSTASIS VALVE AND TUBING SET2Cleared 510(K)
- K931662LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES2Cleared 510(K)
- K932733CORDIS CATHETER SHEATH INTRODUCER2Cleared 510(K)
- K930057ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET2Cleared 510(K)
- K925633BALT INTRODUCER2Cleared 510(K)
- K931102CORDIS NIHON CATHETER SHEATH INTRODUCER2Cleared 510(K)
- K926340NEW LEAD INTRODUCER KITS, VARIOUS MODELS2Cleared 510(K)
- K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET2Cleared 510(K)
- K924456LONG LENGTH PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION2Cleared 510(K)
- K924562CATHETER INTRODUCER2Cleared 510(K)
- K923681EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI2Cleared 510(K)
- K924491INTRODUCER, PERCUTANEOUS -- MODIFICATION2Cleared 510(K)
- K920908OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 12Cleared 510(K)
- K920907OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO2Cleared 510(K)
- K912664TEC ROTATING DUAL HEMOVALVE2Cleared 510(K)
- K920528CATHETER INTRODUCER2Cleared 510(K)
- K915078MORSE HEMOSTATIC CATHETER INTRODUCER SET2Cleared 510(K)
- K920998GORE TUNNELER, MODIFICATION2Cleared 510(K)
- K920779FAST-CATH HEMOSTASIS INTRODUCER2Cleared 510(K)
- K915625INTRODUCER CATHETER2Cleared 510(K)
- K920327DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER2Cleared 510(K)
- K920251USCI HEMAQUET XT INTRODUCER2Cleared 510(K)
- K915421GUIDEWIRE INTRODUCER SET2Cleared 510(K)
- K915553USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING2Cleared 510(K)
- K915167GESCO PER-Q-CATH CATHETER INTRODUCER2Cleared 510(K)
- K914330SOS BLOODLESS NEEDLE2Cleared 510(K)
- K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER2Cleared 510(K)
- K914352CORDIS OBTURATOR2Cleared 510(K)
- K914046THE BIG EASY Y-ADAPTER2Cleared 510(K)
- K914090DAIG FAST CATH(TM) INTRODUCER, MODIFICATION2Cleared 510(K)
- K913801CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL2Cleared 510(K)
- K912961MORSE VASCULAR INTRODUCER SET2Cleared 510(K)
- K911794CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE2Cleared 510(K)
- K911678ROTATING HEMOSTATIC VALVE2Cleared 510(K)
- K911236MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS2Cleared 510(K)
- K910933OLYMPUS ANGIOSCOPY IRRIGATION SHEATH2Cleared 510(K)
- K910688CORDIS PEEL-AWAY INSERTION TOOL2Cleared 510(K)
- K910861PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK2Cleared 510(K)
- K904475ENTREE SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K903463IVT INTRODUCER SHEATH2Cleared 510(K)
- K903410BIO-MEDICUS CANNULA INTRODUCER2Cleared 510(K)
- K903530PERCUTANEOUS INTRODUCERS2Cleared 510(K)
- K903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY2Cleared 510(K)
- K902932DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL2Cleared 510(K)
- K903906PERCUTANEOUS CATHETER INTRODUCER KIT2Cleared 510(K)
- K902275PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K902477WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET2Cleared 510(K)
- K903442ARIES TAPERSEAL(TM) SHEATH2Cleared 510(K)
- K900658INTRODUCER, PERCUTANEOUS2Cleared 510(K)
- K900515MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)2Cleared 510(K)
- K900756ITC INTRODUCER CATHETER2Cleared 510(K)
- K902251SUBCLAVIAN INTRODUCER SET2Cleared 510(K)
- K901391DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER2Cleared 510(K)
- K901452USCI(R) ACCESS(TM) INTRODUCER SET2Cleared 510(K)
- K895580Y-ADAPTER W/THOUY BORST2Cleared 510(K)
- K897041HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS2Cleared 510(K)
- K895044DUAL GUIDE INTRODUCER CATHETER2Cleared 510(K)
- K891121MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM2Cleared 510(K)
- K894446ANGEION HEMOSTASIS VALVE INTRODUCER2Cleared 510(K)
- K895214HEMOSTASIS VALVE2Cleared 510(K)
- K894445MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE2Cleared 510(K)
- K894157OBTURATOR2Cleared 510(K)
- K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO2Cleared 510(K)
- K890766CATHETER INTRODUCER SHEATH2Cleared 510(K)
- K894431MODIFIED LABELING TO PERMANENT LEAD INTRODUCER2Cleared 510(K)
- K894430MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY2Cleared 510(K)
- K885179INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD2Cleared 510(K)
- K893658PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K891022INTRODUCER FOR PTCA GUIDING CATHETERS2Cleared 510(K)
- K890277HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT2Cleared 510(K)
- K884494DAIG OBTURATOR, CATHETER INTRODUCER2Cleared 510(K)
- K884159SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT2Cleared 510(K)
- K884104USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR2Cleared 510(K)
- K882657HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT2Cleared 510(K)
- K883933INTRODUCING CATHETER2Cleared 510(K)
- K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH2Cleared 510(K)
- K882221OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE2Cleared 510(K)
- K875158ACS FUNNEL INTRODUCER2Cleared 510(K)
- K873100OLYMPUS ANGIOSCOPY SHEATH2Cleared 510(K)
- K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO2Cleared 510(K)
- K873727PULL-APART INTRODUCER (SHEATH)2Cleared 510(K)
- K873394OVAL PULL-APART SHEATH/DILATOR2Cleared 510(K)
- K871153CATHETER INTRODUCER2Cleared 510(K)
- K871208UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M2Cleared 510(K)
- K870542VASCATH VASCULAR CATHETER PLACEMENT KIT2Cleared 510(K)
- K871140ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER2Cleared 510(K)
- K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS2Cleared 510(K)
- K870907INTRODUCER, PERCUTANEOUS2Cleared 510(K)
- K870374PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK2Cleared 510(K)
- K870189ARIES TAPERED SHEATH2Cleared 510(K)
- K864705MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH2Cleared 510(K)
- K864352MODIFIED PEEL-AWAY INTRODUCER SET LINE2Cleared 510(K)
- K863917CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.2Cleared 510(K)
- K863139TERUMO RADIFOCUS INTRODUCER KIT2Cleared 510(K)
- K861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO2Cleared 510(K)
- K861238ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV2Cleared 510(K)
- K861951MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER2Cleared 510(K)
- K860307PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET2Cleared 510(K)
- K861082CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST2Cleared 510(K)
- K860898SUBCLAVIAN INTRODUCER SET2Cleared 510(K)
- K860958CATHETER INTRODUCER2Cleared 510(K)
- K855061CURITY PERCUTANEOUS CATHETER INSERTION KIT2Cleared 510(K)
- K855060CURITY PERCUTANEOUS CATHETER INSERTION TRAY2Cleared 510(K)
- K854941PMS PERCUTANEOUS PUNCTURE NEEDLE2Cleared 510(K)
- K860432PERCUTANEOUS INTRODUCER KIT2Cleared 510(K)
- K854831VALVOKIT2Cleared 510(K)
- K855126CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES2Cleared 510(K)
- K854559MEDTRONIC PERMANENT LEAD INTRODUCER2Cleared 510(K)
- K853072CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 902Cleared 510(K)
- K853100COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT2Cleared 510(K)
- K852880PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)2Cleared 510(K)
- K851947PTCA GUIDING CATHETER2Cleared 510(K)
- K852918SLIM ART J. BIP PACING LEAD USING POLY #030-28212Cleared 510(K)
- K852916SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-2842Cleared 510(K)
- K852917SLIM ART/J-SVC IND PACING LEAD USING POLY #30-2832Cleared 510(K)
- K845037PERCUTANEOUS ANGIOGRAPHIC NEEDLES2Cleared 510(K)
- K844593CARDIOVASCULAR CUSTOM SURGICAL KIT2Cleared 510(K)
- K851141TELEFLEX MEDICAL INTRODUCER CATHETER2Cleared 510(K)
- K844840DESERET INTRODUCER SET2Cleared 510(K)
- K851078HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER2Cleared 510(K)
- K850820PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID2Cleared 510(K)
- K844693PEEL-AWAY INTRODUCER SET2Cleared 510(K)
- K843798MEADOX SURGIMED A/S CATHETER SHEATH SYS2Cleared 510(K)
- K843118CANNULA INTRODUCER2Cleared 510(K)
- K843642SUBCLAVIAN LEAD INTRODUCER SYS2Cleared 510(K)
- K843641CATHETER INTRODUCER SYSTEM2Cleared 510(K)
- K843719SINGLE WALL INTRODUCER NEEDLE2Cleared 510(K)
- K843500FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN2Cleared 510(K)
- K842780MEDTRONIC 6210 PERMANENT LEAD INTRODUC2Cleared 510(K)
- K842259PCI W/CATH-SEAL SIDE FLOW FITTING2Cleared 510(K)
- K842004PERCUTANEOUS CATHETER INTRODUCER SET2Cleared 510(K)
- K840455EMERGENCY INFUSION DEVICE2Cleared 510(K)
- K840923ANGIOGRAPHY NEEDLE W/WO CONNECTION2Cleared 510(K)
- K834074PERCUTANEOUS SHEATH INTRODUCER TRAY2Cleared 510(K)
- K831751LEAD INTRODUCER SETS-EB-S8 & EB-S122Cleared 510(K)
- K830829CORONARY GUIDING CATHETER2Cleared 510(K)
- K830813FRENCH PERCUTANEOUS SHEATH INTRODUCER2Cleared 510(K)
- K823262MODEL SP5800 #8 FRENCH INTRO. KIT2Cleared 510(K)
- K822834ACCESS PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K822593PERCUTANEOUS CATHETER INTRODUCER SET2Cleared 510(K)
- K822247CATH-SEAL2Cleared 510(K)
- K821324ARGYLE INTRAMEDICUT CATHETER KIT2Cleared 510(K)
- K821188INTRODUCER SET2Cleared 510(K)
- K820834PERCOR PERCUTANEOUS INTRODUCER2Cleared 510(K)
- K820710NEONATAL INTRODUCER KIT2Cleared 510(K)
- K820581NORTON JUGULAR KITS2Cleared 510(K)
- K813143DESILET2Cleared 510(K)
- K813019PERCUTANEOUS INTRODUCER: SELDINGER STYLE2Cleared 510(K)
- K812973PERCUTANEOUS INTRODUCER COURNAND STYLE2Cleared 510(K)
- K812964INTRODUCER, PERCUTANEOUS SELDINGER2Cleared 510(K)
- K812502IMPLANTAID LEAD INTRODUCER #319-10 & 122Cleared 510(K)
- K812325INTK-08 8 FRENCH INTRODUCER KIT W/SIDE2Cleared 510(K)
- K812143INTRODUCER, PERCUTANEOUS2Cleared 510(K)
- K800356PERMANENT LEAD INTRADUCER2Cleared 510(K)
- K800620VENOUS M/A INTERNAL JUGULAR KIT2Cleared 510(K)
- K800619THERMODILUTION CATHETER INTRO. KIT2Cleared 510(K)
- K800621PERCUTANEOUS CATHETER INTRODUCER ADAPTER2Cleared 510(K)
- K800580PERCUTANEOUS CATHETER INTRODUCER2Cleared 510(K)
- K792171COMPLETE TRAY CENTRAL VENOUS PRESSURE2Cleared 510(K)
- K792170PERCUTANEOUS SHEATH (MULTI-CATH)SIDE2Cleared 510(K)
- K792172PERCUTANEOUS SHEATH INTRO. KIT OR TRAY2Cleared 510(K)
- K792131TEMPORARY TRANSVENOUS PACMKER. ELECTRODE2Cleared 510(K)
- K792130TRANSVENOUS BALLOON CATH. INTRO. KIT2Cleared 510(K)
- K791963USCI MULLINS TRANSSEPTAL CATHETER INTRO.2Cleared 510(K)
- K791129PERMANENT LEAD INTRADUCER2Cleared 510(K)
- K790034INTRODUCERS2Cleared 510(K)
- K781954CATHETER INTRODUCERS, ARTERISE2Cleared 510(K)
- K780532PERCUTANEOUS SHEATH INTRODUCER KIT2Cleared 510(K)
- K771982888 ARTERIAL/VENOUS CATHETER INTRODUCER2Cleared 510(K)
- K771041INTRODUCER, CAT. #INT-06FR.2Cleared 510(K)
- K771042INTRODUCER, CAT. #INT-05FR.2Cleared 510(K)
- K771040INTRODUCER, CAT. #INT-07FR.2Cleared 510(K)
- K770561CATHETER,PERCUTANEOUS INTRODUC. & SHEATH2Cleared 510(K)
- K770427CATHETER INTRODUCER KIT2Cleared 510(K)
- 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
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MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K080500
- 510(k) Type
- Special
- Applicant
- ACUMEN MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/13/2008
- Days to Decision
- 17 days
- Submission Type
- Summary