Vascutek L T D

FDA Filings

This page includes the latest FDA filings for Vascutek L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9612515
FEI Number3002808437
NameVASCUTEK LTD.
Owner & OperatorVASCUTEK LTD.
Contact AddressNEWMAINS AVE.
INCHINNAN GB-RFW Renfrewshire PA4 9RR GB
Official Correspondent
  • Megan Indeglia
  • 44-0-1418125555-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNEWMAINS AVE.
INCHINNAN, RENFREWSHIRE Renfrewshire, PA4 9RR GB
Establishment Type
  • Manufacture Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device
Company
DeviceDate
VASCUTEK LTD
 Gelweave Vascular Prostheses 732032E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732030E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731038E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731036E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731030E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733038E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733036E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733034E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733032E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733030E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733028E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733026E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733024E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733022E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733020E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733018E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731228E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731226E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731224E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731220E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732528E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732526E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732524E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732520E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 732518E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 730528E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 730526E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735034E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735032E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735030E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735028E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735026E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735024E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735022E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 735020E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731516E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731512E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731511E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731510E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731508E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731507E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 731506E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733016E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733014E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733012E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733011E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733010E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733008E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733007E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 733006E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 734006E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736012E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736011E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736010E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736009E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736008E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736007E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632211P50E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632010P50E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631809P50E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631407P50E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631206P50E2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632211PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631809PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631608PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631407PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631224PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631222PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631220PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631218PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631516PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631514PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631512PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631510PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631507PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631506PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632524PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632522PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633016PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633014PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633012PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633010PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633008PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633007PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 633006PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 634008PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 634007PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 634006PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 635024PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 635022PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 635020PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 635018PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636016PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636014PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636012PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636010PE2025-04-08
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636006PE2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736006E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736028/12x4E2025-04-08
VASCUTEK LTD
 Gelweave Vascular Prostheses 736026/12x4E2025-04-08
Vascutek Ltd
Vascutek Gelsoft Plus ERS Vascular Graft2021-04-06
Vascutek Ltd
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2020-07-08
VASCUTEK LTD.
Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelseal Vascular Grafts, Gelsoft Vascular Grafts,2019-02-18
VASCUTEK LTD.
Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelweave Vascular Grafts2019-02-18
VASCUTEK LTD.
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts2017-07-14
VASCUTEK LTD.
Gelweave Vascular Grafts2017-06-30
VASCUTEK LTD.
Gelseal Vascular Grafts2011-12-18
VASCUTEK LTD.
SEALPTFE vascular graft2011-12-18
VASCUTEK LTD.
ePTFE vascular grafts2011-12-18
VASCUTEK LTD.
Gelsoft vascular graft2011-12-18
VASCUTEK LTD.
Fluoropassiv caridovascular fabric2011-12-18
VASCUTEK LTD.
Twillweave vascular graft2011-12-18
VASCUTEK LTD.
Gelweave vascular grafts2011-12-18
VASCUTEK LTD.
Cardiovascular fabric:Gelseal patch, Gelsoft patch, thinwall carotid patch2011-12-18
VASCUTEK LTD.
Graft Sizer Set2011-12-18
VASCUTEK LTD.
Gelsoft Plus Vascular Graft2011-12-18
VASCUTEK LTD.
Gelweave vascular grafts2011-12-18
VASCUTEK LTD.
VP1200K Vascular Graft2011-12-18
VASCUTEK LTD.
Extra Soft/Low Woven Vascular Graft2011-12-18
VASCUTEK LTD.
Extra Soft/Low Woven Vascular Graft2011-12-18
VASCUTEK LTD.
VP1200K/VP50K2011-12-18
VASCUTEK LTD.
Gelweave branched vascular grafts with radiopaque markers2011-12-18
VASCUTEK LTD.
Maxiflo and Taperflo ePTFE Vascular Grafts (wrapped tapers)2011-12-18
VASCUTEK LTD.
Cobrahood ePTFE vascular graft2011-12-18
VASCUTEK LTD.
Gelweave branched grafts and Siena grafts with and without radiopaque markers2011-12-18
VASCUTEK LTD.
Cannula graft2011-12-18
VASCUTEK LTD.
Temporary limb salvage shunt2011-12-18
VASCUTEK LTD.
Gelweave Siena collared ante-flo and plexus with radiopaque markers2011-12-18
VASCUTEK LTD.
ePTFE vascular grafts, SealPTFE:PTFE supported2011-12-18
VASCUTEK LTD.
ePTFE wrapped ePTFE vascular graft2011-12-18
VASCUTEK LTD.
Gelweave ante-flo and 4 branch plexus with collar2011-12-18
VASCUTEK LTD.
Gelsoft Plus ERS2011-12-18
VASCUTEK LTD.
ePTFE vascular grafts, SealPTFE (with ePTFE support)2011-12-18
VASCUTEK LTD.
Gelweave Valsalva2011-12-18
VASCUTEK LTD.
Gelsoft ERS Vascular Graft2011-12-18
VASCUTEK LTD.
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS2010-01-07
VASCUTEK LTD.
MAXIFLO, TAPERFLO2009-10-08
VASCUTEK LTD.
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS2009-08-31
VASCUTEK LTD.
VASCUTEK BRANCHED GELWEAVE2009-06-19
VASCUTEK LTD.
VASCUTEK CANNULA GRAFT, MODEL CGS2008S2009-02-10
VASCUTEK LTD.
TEMPORARY LIMB SALVAGE SHUNT2007-02-15
VASCUTEK LTD.
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS2006-02-07
VASCUTEK LTD.
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES2005-01-05
VASCUTEK LTD.
MODIFICATION TO EPTFE GRAFT2004-09-14
VASCUTEK LTD.
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR2004-05-20
VASCUTEK LTD.
GELSOFT PLUS ERS2004-02-19
VASCUTEK LTD.
EPTFE VASCULAR PROSTHESIS; SEALPTFE2003-04-09
VASCUTEK LTD.
VASCUTEK TWILLWEAVE VASCULAR GRAFT1997-03-10
VASCUTEK LTD.
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH1996-11-21
VASCUTEK LTD.
VASCUTEK GELSOFT PLUS VASCULAR GRAFT1996-02-09
VASCUTEK LTD.
VASCUTEK GELWEAVE VASCULAR GRAFT1995-12-19
VASCUTEK LTD.
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS1991-04-01
VASCUTEK LTD.
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS1991-04-01
VASCUTEK LTD.
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS1991-04-01
VASCUTEK LTD.
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS1991-04-01

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