Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)2Cleared 510(K)
- K241550Gelweave™ Vascular Prostheses2Cleared 510(K)
- K241070Gelsoft™ Plus Vascular Prostheses2Cleared 510(K)
- K231972Advanta VXT Vascular Graft, Flixene Vascular Graft2Cleared 510(K)
- K240083GORE® PROPATEN® Vascular Graft2Cleared 510(K)
- K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts2Cleared 510(K)
- K232312GORE® PROPATEN® Vascular Graft2Cleared 510(K)
- K233551GORE® ACUSEAL Vascular Graft2Cleared 510(K)
- K231505GORE® ACUSEAL Vascular Graft2Cleared 510(K)
- K213845HeRO Graft2Cleared 510(K)
- K221628exGraft, exGraft Carbon2Cleared 510(K)
- K203724HeRO Graft, HeRO Adapter2Cleared 510(K)
- K202703Vascutek Gelsoft Plus ERS Vascular Graft2Cleared 510(K)
- K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft2Cleared 510(K)
- K183613exGraft, exGraft Carbon2Cleared 510(K)
- K180957exGraft, exGraft Carbon ePTFE Vascular Grafts2Cleared 510(K)
- K172637HeRO Graft2Cleared 510(K)
- K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts2Cleared 510(K)
- K162794Gelweave Vascular Grafts2Cleared 510(K)
- K153523FUSION Vascular Graft2Cleared 510(K)
- K150389Spiral Flow Peripheral Vascular Graft2Cleared 510(K)
- K142062SPIRAL FLOW PERIPHERAL VASCULAR GRAFT2Cleared 510(K)
- K141124SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT2Cleared 510(K)
- K131778FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT2Cleared 510(K)
- K130215GORE ACUSEAL VASCULAR GRAFT2Cleared 510(K)
- K130142FLIXENE IFG VASCULAR GRAFT2Cleared 510(K)
- K124039HERO GRAFT2Cleared 510(K)
- K130016LIFESPAN EPTFE VASCULAR GRAFT2Cleared 510(K)
- K122138ATRIUM FLIXENE IFG VASCULAR GRAFT2Cleared 510(K)
- K121532HERO GRAFT2Cleared 510(K)
- K120006HERO GRAFT2Cleared 510(K)
- K113101EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL2Cleared 510(K)
- K103347CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES2Cleared 510(K)
- K102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2Cleared 510(K)
- K094044SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT2Cleared 510(K)
- K093934GORE HYBRID VASCULAR GRAFT2Cleared 510(K)
- K093817GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS2Cleared 510(K)
- K092863MAXIFLO, TAPERFLO2Cleared 510(K)
- K091778VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS2Cleared 510(K)
- K091491HERO VASCULAR ACCESS DEVICE2Cleared 510(K)
- K090987VASCUTEK BRANCHED GELWEAVE2Cleared 510(K)
- K083169EPTFE SLFTM SPIRAL VASCULAR GRAFT2Cleared 510(K)
- K071778HERO VASCULAR ACCESS DEVICE2Cleared 510(K)
- K071923PTFE FLIXENE GRADUATED WALL GRAFT2Cleared 510(K)
- K062161GORE PROPATEN VASCULAR GRAFT2Cleared 510(K)
- K061626VASORING* VRC VASCULAR RING CONNECTOR2Cleared 510(K)
- K060741SWIRLGRAFT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K060124ATRIUM FLIXENE GRAFT2Cleared 510(K)
- K060142VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS2Cleared 510(K)
- K052964EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN2Cleared 510(K)
- K051312SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS2Cleared 510(K)
- K051332ADVANTA T-GRAFT2Cleared 510(K)
- K052282VENAFLO II VASCULAR GRAFT2Cleared 510(K)
- K050049DYNAFLO BYPASS GRAFT2Cleared 510(K)
- K043552VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES2Cleared 510(K)
- K041528MODIFICATION TO EPTFE GRAFT2Cleared 510(K)
- K040829GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR2Cleared 510(K)
- K034010GELSOFT PLUS ERS2Cleared 510(K)
- K032900LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS2Cleared 510(K)
- K030999EPTFE VASCULAR PROSTHESIS; SEALPTFE2Cleared 510(K)
- K021547FLOWLINE BIOPORE EPTFE VASCULAR GRAFT2Cleared 510(K)
- K022242INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER2Cleared 510(K)
- K013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS2Cleared 510(K)
- K020767ADVANTA SST BIFURCATED GRAFT2Cleared 510(K)
- K013651INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS2Cleared 510(K)
- K013577ULTRAMAX WOVEN VELOUR VASCULAR GRAFT2Cleared 510(K)
- K013250GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT2Cleared 510(K)
- K012952HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT2Cleared 510(K)
- K010516ADVANTA SST GRAFT (>_6MM)2Cleared 510(K)
- K010517ADVANTA SST GRAFT (<6MM)2Cleared 510(K)
- K004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS2Cleared 510(K)
- K002007SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS2Cleared 510(K)
- K990800INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS2Cleared 510(K)
- K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME2Cleared 510(K)
- K000499ADVANTA SUPER SOFT GRAFT2Cleared 510(K)
- K993667SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS2Cleared 510(K)
- K990503SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS2Cleared 510(K)
- K992832SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS2Cleared 510(K)
- K992960ADVANTA GRAFT (>6MM)2Cleared 510(K)
- K992443ADVANTA GRAFT2Cleared 510(K)
- K991602EPTFE RINGED GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K991813UNI-GRAFT K DV VASCULAR GRAFT2Cleared 510(K)
- K991027BI-DIRECTIONAL TUNNELER2Cleared 510(K)
- K984294MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES2Cleared 510(K)
- K984182PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 314522Cleared 510(K)
- K983861DISTAFLO BYPASS GRAFT2Cleared 510(K)
- K983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN2Cleared 510(K)
- K983064IMPRA HIGH POROSITY GRAFT2Cleared 510(K)
- K981079VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT2Cleared 510(K)
- K963790UNI-GRAFT K DV2Cleared 510(K)
- K970843INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES2Cleared 510(K)
- K964625HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES2Cleared 510(K)
- K971192IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT2Cleared 510(K)
- K962433MEADOX EXXCEL EPTFE VASCULAR GRAFT2Cleared 510(K)
- K964959VASCUTEK TWILLWEAVE VASCULAR GRAFT2Cleared 510(K)
- K964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)2Cleared 510(K)
- K961847HEMASHIELD VANTAGE (VASCULAR GRAFT2Cleared 510(K)
- K964197IMPRA CARBOFLO EPTFE VASCULAR GRAFT2Cleared 510(K)
- K962639IMPRA CARBOFLO EPTFE VASCULAR GRAFT2Cleared 510(K)
- K961134BARD GRAFT SIZER2Cleared 510(K)
- K955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT2Cleared 510(K)
- K960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT2Cleared 510(K)
- K955532DIASTAT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K955588VASCUTEK GRAFT SIZER SET2Cleared 510(K)
- K955230VASCUTEK GELSOFT PLUS VASCULAR GRAFT2Cleared 510(K)
- K952293VASCUTEK GELWEAVE VASCULAR GRAFT2Cleared 510(K)
- K954582BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)2Cleared 510(K)
- K953288DIASTAT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K944858BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS2Cleared 510(K)
- K941981AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED2Cleared 510(K)
- K940816BARD(R) EXPANDED PTFE VASCULAR GRAFT2Cleared 510(K)
- K933987AOR-TEX VASCULAR GRAFT2Cleared 510(K)
- K940062DIASTAT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K933590BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT2Cleared 510(K)
- K933943FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS2Cleared 510(K)
- K933204BARD PTFE VASCULAR GRAFT2Cleared 510(K)
- K925123ATRIUM'S HYBRID PTFE2Cleared 510(K)
- P840029HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM2PMA Approval
- P840029HEMASHIELD ETS(TM) FLANGED GRAFT2PMA Approval
- P840029HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM2PMA Approval
- P840029HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS2PMA Approval
- K922905FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT2Cleared 510(K)
- K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF2Cleared 510(K)
- K914116PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION2Cleared 510(K)
- K914447GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE2Cleared 510(K)
- K913143OCHSNER ULP BIFURCATION VASCULAR PROTHESIS2Cleared 510(K)
- K912911LOW POROSITY (LP) VASCULAR PROSTHESIS2Cleared 510(K)
- K905269OCHSNER 500 VASCULAR PROSTHESIS2Cleared 510(K)
- K910865TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS2Cleared 510(K)
- K910863EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS2Cleared 510(K)
- K910864EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS2Cleared 510(K)
- K910866VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS2Cleared 510(K)
- K905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT2Cleared 510(K)
- K905270OCHSNER 50 VASCULAR PROSTHESIS2Cleared 510(K)
- K904282BIFURCATED GORE TEX STRETCH VASCULAR GRAFT2Cleared 510(K)
- K903931GORE-TEX(R) STRETCH VASCULAR GRAFT2Cleared 510(K)
- K903964OCHSNER 50 BIFURCATION2Cleared 510(K)
- K901641AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- P840029MICROVEL(R) WITH HEMASHIELD2PMA Approval
- K901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS2Cleared 510(K)
- K896964PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.2Cleared 510(K)
- K890182PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV2Cleared 510(K)
- K894732VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)2Cleared 510(K)
- K890597EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS2Cleared 510(K)
- K893459PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)2Cleared 510(K)
- P840029MICROVEL(R) WITH HEMASHIELD2PMA Approval
- K884083TORAY VASCULAR PROSTHESIS2Cleared 510(K)
- K882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.2Cleared 510(K)
- K882314CORONARY VEIN GRAFT MARKER2Cleared 510(K)
- K880041VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT2Cleared 510(K)
- K880040VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT2Cleared 510(K)
- K881283MEADOX INTRA-AORTIC GRAFT2Cleared 510(K)
- K880167GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K870884RADIALLY-SUPPORTED VASCULAR PROSTHESES2Cleared 510(K)
- K871110CORONARY ARTERY BYPASS GRAFT (CABG) MARKER2Cleared 510(K)
- K862697AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)2Cleared 510(K)
- K861808VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN2Cleared 510(K)
- K862739INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES2Cleared 510(K)
- K854845INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR2Cleared 510(K)
- K841596MEADOS INTRAORTIC GRAFT2Cleared 510(K)
- K854431MEADOX MEDICALS INC. GRAFT SIZER2Cleared 510(K)
- K853101VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES2Cleared 510(K)
- K853725ATRIUM PLASMA TFE SYNTHETIC ARTERY2Cleared 510(K)
- K831822TETRAFLEX INTEGRALLY SUPPORTED PTFE2Cleared 510(K)
- K833716LP200 & HP800 SERIES VASCULAR PROSTH2Cleared 510(K)
- K830016VASCUTEK VASCULAR PROTHESIS VP1200K/50K2Cleared 510(K)
- K831880IONESCU-SHILEY LOW POROSITY AORTIC GRAFT2Cleared 510(K)
- K831865IONESCU-SHILEY LOW POROSITY COMPOSITE2Cleared 510(K)
- K832806CORONARY ANASTOMOSIS MARKING SYSTEM2Cleared 510(K)
- K830543VASCULAR GRAFT PROSTHESIS EXPANDED MICR2Cleared 510(K)
- K822633MICROVEL DOUBLE VELOUR SUPPORTED 1002Cleared 510(K)
- K821716BARD PTFE VASCULAR PROSTHESIS2Cleared 510(K)
- K820696MEADOX WOVEN DOUBLE VELOUR2Cleared 510(K)
- K820600HANCOCK VASCULAR GRAFT2Cleared 510(K)
- K821158FED RINGED-TEX VASCULAR GRAFT2Cleared 510(K)
- K812248COOLEY 2 VASCULAR PROSTHESIS STRAIGHT2Cleared 510(K)
- K811441MANUFACTURING PROCESS CHANGE2Cleared 510(K)
- K811510GORE-TEX VASULAR GRAFT2Cleared 510(K)
- K810845DOUBLE VELOUR GRAFTS2Cleared 510(K)
- K810376MEADOX SZILAGYI GRAFT2Cleared 510(K)
- K803000IONESCU-SHILEY AORTIC GRAFT VALVE2Cleared 510(K)
- K802095GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K801621VASCULAR GRAFT PROSTH. OF EXP. MICRO.2Cleared 510(K)
- K801156USCI INTRALUMINAL GRAFT W/DACRON TIE2Cleared 510(K)
- K800149USCI SAUVAGE EXS VASCULAR PROSTHESIS2Cleared 510(K)
- K791828BJORK-SHILEY PULMONIC GRAFT VALVE2Cleared 510(K)
- K771819CABG RINGS2Cleared 510(K)
- K770236SAUVAGE FILAMENTOUS PROSTHESES2Cleared 510(K)
- K770235DEBAKEY VASCULOUR-D PROSTHESES2Cleared 510(K)
- K760130PROSTHESIS, VASCULAR BIFURCATED2Cleared 510(K)
- K760091GRAFT, MICROVEL GUIDELINE, STERILE2Cleared 510(K)
- K760090GRAFT, COOLEY GUIDELINE, STERILE2Cleared 510(K)
- K760092GRAFT, COOLEY WOVEN VASCULAR, STERILE2Cleared 510(K)
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- 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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VASCUTEK TWILLWEAVE VASCULAR GRAFT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K964959
- 510(k) Type
- Traditional
- Applicant
- VASCUTEK LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking Regulation
- Decision Date
- 3/10/1997
- Days to Decision
- 89 days