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 736022ST/10DE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736026ST/10DE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732412810/10STDE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734022/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732028/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735024/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735032/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734022/10SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734026/10SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734030/10SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734032/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734034/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732022/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732030/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732032/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735024/8SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735032/8SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 733032/10SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736022/8SE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735022/10SEE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 733018/6AE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 733024/6AE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734022/10RMAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734030/10RMAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734032/10RMAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734034/10RMAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732014/8X2E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732212/10/8ARME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732214/10/10CRME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731608/7x2RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732514/10X3E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73221088/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73301088/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73341088/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73221088/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73261088/10E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73281088/10SAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73301088/10SAE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73140778/8RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73201288/8AE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73301288/8AE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73321288/8AE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73241488/8ARME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73261488/8ARME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73301488/8ARME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732030CX4E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732034CX4E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732026CX4RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734026CX4RMSE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 7328668/6E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 7322888/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 7324888/8E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732810108/8S4E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 733010108/8S4E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734532/8ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734526/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734528/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734532/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73201088/8ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73281088/8ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73241088/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73321088/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73281412/10ETE2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735020RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735022RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735024RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735022/8RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 735032/10RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 73261088/8RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 7332101088/14E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732610108/8RME2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736034E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736032E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736020E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 736018E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734034E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 734030E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 732034E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731034E2025-05-21
VASCUTEK LTD
 Gelweave Vascular Prostheses 731032E2025-05-21
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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