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
Vascutek Gelweave™ Vascular Grafts 732014/8X2A2023-09-08
VASCUTEK LTD
Vascutek Gelweave™ Vascular Grafts 7314108/10RM2023-09-08
VASCUTEK LTD
Vascutek Gelweave™ Vascular Grafts 7314108/8RM2023-09-08
VASCUTEK LTD
Vascutek Gelweave™ Vascular Grafts 7312108/10RM2023-09-08
VASCUTEK LTD
Vascutek Gelweave™ Vascular Grafts 7312108/8RM2023-09-08
VASCUTEK LTD
Gelweave™ 733010108/8RM2022-06-08
VASCUTEK LTD
Gelweave™ 732810108/8RM2022-06-08
VASCUTEK LTD
Gelweave™ 732610108/8RM2022-06-08
VASCUTEK LTD
Gelweave™ 732410108/8RM2022-06-08
VASCUTEK LTD
Gelweave™ 732210108/8RM2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3240X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3040X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3038X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3036X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3034X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3032X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2830X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2628X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2426X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2224X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3240X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3040X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3038X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3036X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3034X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA3032X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2830X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2628X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2426X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THA2224X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3240X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3040X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3038X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3036X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3034X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3032X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2830X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2628X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2426X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2224X150A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3240X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3040X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3038X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3036X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3034X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP3032X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2830X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2628X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2426X100A2022-06-08
VASCUTEK LTD
Thoraflex™ Hybrid THP2224X100A2022-06-08
VASCUTEK LTD
Gelweave™ 732010108/8RM2022-04-20
VASCUTEK LTD
Gelsoft Plus™ 691008BP2021-04-22
VASCUTEK LTD
Gelsoft Plus™ 690807BP2021-04-22
Vascutek Ltd
Vascutek Gelsoft Plus ERS Vascular Graft2021-04-06
VASCUTEK LTD
SealPTFE™ T3005S2021-01-20
VASCUTEK LTD
Gelsoft™ Cardiovascular Patch 961001S2020-07-24
VASCUTEK LTD
Gelsoft™ Cardiovascular Patch 960701S2020-07-24
Vascutek Ltd
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2020-07-08
VASCUTEK LTD
Gelweave™ 73108/8X22020-04-07
VASCUTEK LTD
Gelweave™ 7330092020-04-01
VASCUTEK LTD
Gelweave™ 73128/10X22020-03-31
VASCUTEK LTD
Gelweave™ 731010/8X22020-03-31
VASCUTEK LTD
Gelweave™ 731210/8X22020-03-31
VASCUTEK LTD
SealPTFE™ T50S06CR36SH2020-03-25
VASCUTEK LTD
SealPTFE™ S7005PS2020-03-25
VASCUTEK LTD
MAXIFLO™ S2005P2020-03-25
VASCUTEK LTD
Gelseal™ 4315062020-03-25
VASCUTEK LTD
Gelweave™ 735030/8rmst2020-03-25
VASCUTEK LTD
Gelweave™ 735028/8rmst2020-03-25
VASCUTEK LTD
Gelweave™ 735026/8rmst2020-03-25
VASCUTEK LTD
Gelweave™ 735024/8rmst2020-03-25
VASCUTEK LTD
Gelweave™ 735022/8rmst2020-03-25
VASCUTEK LTD
Gelweave™ 73261210/9RMC2020-03-25
VASCUTEK LTD
Gelweave™ 733024/6S2020-03-25
VASCUTEK LTD
Gelweave™ 733022/6S2020-03-25
VASCUTEK LTD
Gelweave™ 733020/6S2020-03-25
VASCUTEK LTD
Gelweave™ 733018/6S2020-03-25
VASCUTEK LTD
Gelweave™ 734034/10RMA2020-03-25
VASCUTEK LTD
Gelweave™ 734032/10RMA2020-03-25
VASCUTEK LTD
Gelweave™ 734030/10RMA2020-03-25
VASCUTEK LTD
Cannula Graft™ CGS2008S2020-03-25
VASCUTEK LTD
SealPTFE™ S40S06CRSH2020-03-25
VASCUTEK LTD
SealPTFE™ T1005S2020-03-25
VASCUTEK LTD
SealPTFE™ S8005S2020-03-25
VASCUTEK LTD
SealPTFE™ S7005S2020-03-25
VASCUTEK LTD
SealPTFE™ S6005S2020-03-25
VASCUTEK LTD
MAXIFLO™ S10052020-03-25
VASCUTEK LTD
Gelweave™ 736032/10S2020-03-24
VASCUTEK LTD
MAXIFLO™ S2010P2020-03-24
VASCUTEK LTD
Gelweave™ 733410/10RM2020-03-24
VASCUTEK LTD
Gelweave™ 733014/10/82020-03-24
VASCUTEK LTD
Gelweave™ 733014/8/102020-03-24
VASCUTEK LTD
Gelweave™ 733012/10/82020-03-24
VASCUTEK LTD
Gelweave™ 733012/8/102020-03-24
VASCUTEK LTD
Gelweave™ 734032/8K2020-03-24
VASCUTEK LTD
Gelweave™ 734030/8K2020-03-24
VASCUTEK LTD
Gelweave™ 734028/8K2020-03-24
VASCUTEK LTD
Gelweave™ 734026/8K2020-03-24
VASCUTEK LTD
Gelweave™ 734024/8K2020-03-24
VASCUTEK LTD
SealPTFE™ T80S08RS2020-03-24
VASCUTEK LTD
SealPTFE™ S80S07RS2020-03-24
VASCUTEK LTD
Gelsoft Plus™ 631005P2020-03-24
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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