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
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™ 733026/10S2020-03-24
VASCUTEK LTD
Gelweave™ 733028/10S2020-03-24
VASCUTEK LTD
Gelweave™ 733030/10S2020-03-24
VASCUTEK LTD
Gelweave™ 733032/10S2020-03-24
VASCUTEK LTD
Gelweave™ 736030/10S2020-03-24
VASCUTEK LTD
Gelweave™ 736032/10S2020-03-24
VASCUTEK LTD
SealPTFE™ T3010PS2020-03-24
VASCUTEK LTD
SealPTFE™ T2010PS2020-03-24
VASCUTEK LTD
SealPTFE™ T1006PS2020-03-24
VASCUTEK LTD
SealPTFE™ S3010PS2020-03-24
VASCUTEK LTD
SealPTFE™ S2008PS2020-03-24
VASCUTEK LTD
SealPTFE™ S2007PS2020-03-24
VASCUTEK LTD
SealPTFE™ S1010PS2020-03-24
VASCUTEK LTD
SealPTFE™ S1008PS2020-03-24
VASCUTEK LTD
MAXIFLO™ S2010P2020-03-24
VASCUTEK LTD
Gelweave™ 731210/8X22020-03-24
VASCUTEK LTD
Gelweave™ 731010/8X22020-03-24
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™ S5006EPS2020-03-24
VASCUTEK LTD
Cobrahood™ H60072020-03-24
VASCUTEK LTD
Cobrahood™ H60062020-03-24
VASCUTEK LTD
Cobrahood™ H50082020-03-24
VASCUTEK LTD
Cobrahood™ H50072020-03-24
VASCUTEK LTD
Cobrahood™ H50062020-03-24
VASCUTEK LTD
Cobrahood™ H40082020-03-24
VASCUTEK LTD
Cobrahood™ H40072020-03-24
VASCUTEK LTD
Cobrahood™ H40062020-03-24
VASCUTEK LTD
Gelweave™ 73261288/8A2020-03-24
VASCUTEK LTD
Gelweave™ 73241288/8A2020-03-24
VASCUTEK LTD
Gelweave™ 73221288/8A2020-03-24
VASCUTEK LTD
Gelweave™ 734026CX4RMS2020-03-24
VASCUTEK LTD
SealPTFE™ T80S08RS2020-03-24
VASCUTEK LTD
SealPTFE™ T80S06RS2020-03-24
VASCUTEK LTD
SealPTFE™ T70S06RS2020-03-24
VASCUTEK LTD
SealPTFE™ T10S06RS2020-03-24
VASCUTEK LTD
SealPTFE™ S80S07RS2020-03-24
VASCUTEK LTD
SealPTFE™ S10S06S2020-03-24
VASCUTEK LTD
Gelweave™ 73248812202020-03-24
VASCUTEK LTD
Gelweave™ 735030RMS2020-03-24
VASCUTEK LTD
Gelweave™ 732488122020-03-24
VASCUTEK LTD
Gelweave™ 730034ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730032ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730030ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730028ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730026ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730024ADPSL2020-03-24
VASCUTEK LTD
Gelweave™ 730020ADP2020-03-24
VASCUTEK LTD
Gelweave™ 731608/7X2RM2020-03-24
VASCUTEK LTD
Gelweave™ 731407/6X2RM2020-03-24
VASCUTEK LTD
Gelweave™ 731206/5x2RM2020-03-24
VASCUTEK LTD
Gelweave™ 732212/10/8A2020-03-24
VASCUTEK LTD
Gelweave™ 732030CX42020-03-24
VASCUTEK LTD
Gelweave™ 732024CX42020-03-24
VASCUTEK LTD
Gelweave™ 7310362020-03-24
VASCUTEK LTD
Gelweave™ 73301412/10ET2020-03-24
VASCUTEK LTD
Gelweave™ 73281412/10ET2020-03-24
VASCUTEK LTD
Gelweave™ 73261412/10ET2020-03-24
VASCUTEK LTD
Gelsoft Plus™ 631005P2020-03-24
VASCUTEK LTD
Gelweave™ 732014/8X22020-03-24
VASCUTEK LTD
Gelweave™ 734018/82020-03-24
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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