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
 Thoraflex™ Hybrid THA3240X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3040X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3038X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3036X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3034X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3032X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2830X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2628X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2426X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3240X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3040X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3038X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3036X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3034X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3032X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2830X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2628X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2426X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2224X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2224X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3240X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3040X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3038X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3036X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3034X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3032X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2830X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2628X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2426X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2224X150E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3240X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3040X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3038X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3036X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3034X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3032X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2830X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2628X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2426X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2224X100E2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3240X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3040X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3038X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3036X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3034X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3032X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2830X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2628X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2426X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2224X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3240X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3040X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3038X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3036X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3034X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA3032X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2830X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2628X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2426X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THA2224X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3240X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3040X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3038X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3036X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3034X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3032X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2830X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2628X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2426X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2224X150B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3240X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3040X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3038X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3036X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3034X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP3032X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2830X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2628X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2426X100B2025-09-12
VASCUTEK LTD
 Thoraflex™ Hybrid THP2224X100B2025-09-12
VASCUTEK LTD
 Gelweave Vascular Prostheses 731222E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731218E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732522E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735018E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731514E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731509E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 733009E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734008E2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632412P50E2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631608P50E2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632412PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632010PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631206PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 631508PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632520PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 632518PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636008PE2025-05-21
VASCUTEK LTD
 Gelsoft Plus Vascular Prostheses 636007PE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736016E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736014E2025-05-21
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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