FDA.report

VASCUTEK LTD.

Matched from indexed company URL: VASCUTEK LTD

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96125153002808437VASCUTEK LTD.1N2026-01-01Newmains Avenue Inchinnan Renfrewshire GB PA4 9RR

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1364301817911300P890045GELSEAL TM TRIAXIAL VASCULAR GRAFTMAL1993-01-11
1364301794735957P210006Thoraflex™ HybridQSK 2022-04-19
1364301632797162K993667SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESISDSY2000-01-28
1364301730747141K992832SULZER VASCUTEK EPTFE VASCULAR PROSTHESISDSY1999-11-19
1364301413801974K990503SULZER VASCUTEK GELSOFT VASCULAR PROSTHESISDSY1999-12-09
1364301474280689K972201PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENEDXZ1998-04-14
1364301558789563K964959VASCUTEK TWILLWEAVE VASCULAR GRAFTDSY1997-03-10
1364301823466158K964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)DSY1997-02-19
1364301725702886K963611VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCHDXZ1996-11-21
1364301145274976K955588VASCUTEK GRAFT SIZER SETDSY1996-03-07
1364301068294942K955230VASCUTEK GELSOFT PLUS VASCULAR GRAFTDSY1996-02-09
1364301678766938K952293VASCUTEK GELWEAVE VASCULAR GRAFTDSY1995-12-19
1364301141063950K910866VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESISDSY1991-04-01
1364302049915429K910863EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESISDSY1991-04-01
1364301535531330K861808VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVENDSY1986-09-15
1364301143443647K830016VASCUTEK VASCULAR PROTHESIS VP1200K/50KDSY1983-12-21
1364301397861094K241550Gelweave™ Vascular ProsthesesDSY2025-02-27
1364301513822340K241070Gelsoft™ Plus Vascular ProsthesesDSY2024-11-15
1364301676275250K202703Vascutek Gelsoft Plus ERS Vascular GraftDSY2021-04-06
1364301276971986K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ2020-07-08
1364301303297041K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsDSY2017-07-14
1364301606053167K162794Gelweave Vascular GraftsDSY2017-06-30
1364301981302677K094044SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFTDSY2010-03-23
1364301458737339K093817GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERSDSY2010-01-07
1364302007922232K092863MAXIFLO, TAPERFLODSY2009-10-08
1364301177230498K091778VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTSDSY2009-08-31
1364301832057011K090987VASCUTEK BRANCHED GELWEAVEDSY2009-06-19
1364301797830246K083169EPTFE SLFTM SPIRAL VASCULAR GRAFTDSY2009-03-30
1364302023215895K081560VASCUTEK CANNULA GRAFT, MODEL CGS2008SDWF2009-02-10
1364301906037974K070323TEMPORARY LIMB SALVAGE SHUNTDXC2007-02-15
1364301567846789K060142VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERSDSY2006-02-07
1364301649533837K043552VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESESDSY2005-01-05
1364301717929663K041528MODIFICATION TO EPTFE GRAFTDSY2004-09-14
1364301287782613K040829GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLARDSY2004-05-20
1364301766083870K034010GELSOFT PLUS ERSDSY2004-02-19
1364301622901999K030999EPTFE VASCULAR PROSTHESIS; SEALPTFEDSY2003-04-09
1364301900132028K013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESISDSY2002-06-13
1364301995167615K002007SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESISDSY2001-01-25
1364301283875299
1364301322464189
1364301728014096
1364301749635783
1364301866328712
1364302052251209

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DSY312025-02-27
DXZ32020-07-08
QSK 12022-04-19
DWF12009-02-10
DXC12007-02-15
MAL11993-01-11

PMA

Thoraflex™ Hybrid

2022-09-29

Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indi...

Thoraflex Hybrid

2022-06-16

Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

Thoraflex™ Hybrid

2022-04-19

Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK  Advisory Committee Cardiovascular Clinical TrialsNCT02724072 Expedited Review Granted? No

PMN

Applications

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