FDA.reportPublic FDA data

Cardiovascular patch, animal-derived

Definition
A sterile implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
GUDID devices
177
Last updated
2020-10-30 08:00:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840663106097XenoSure Biologic PatchLemaitre Vascular, Inc.1BV102020-10-22
00840663106745XenoSure Biologic PatchLemaitre Vascular, Inc.0.6BV82020-10-21
05037881010649Gelsoft™ Cardiovascular PatchVASCUTEK LTD960701S2020-07-16
05037881010663Gelsoft™ Cardiovascular PatchVASCUTEK LTD961001S2020-07-16
09348992000594CardioCel Cardiovascular PatchADMEDUS REGEN PTY LTDUC04042020-04-30
00840663104543AlboSure Vascular PatchLemaitre Vascular, Inc.AP06075T2015-07-15
00840663104604AlboSure Vascular PatchLemaitre Vascular, Inc.AP08075T2015-07-15
00840663104765AlboSure Vascular PatchLemaitre Vascular, Inc.AP10075T2015-07-15
00840663104802AlboSure Vascular PatchLemaitre Vascular, Inc.AP10100R2015-07-15
00840663104895AlboSure Vascular PatchLemaitre Vascular, Inc.AP10150R2015-07-15
00840663105021AlboSure Vascular PatchLemaitre Vascular, Inc.AP20090R2015-07-15
00840663106288XenoSure Biologic PatchLemaitre Vascular, Inc.e1P62015-07-15
00840663106295XenoSure Biologic PatchLemaitre Vascular, Inc.e0.8P82015-07-15
00840663106301XenoSure Biologic PatchLemaitre Vascular, Inc.e2P92015-07-15
00840663106318XenoSure Biologic PatchLemaitre Vascular, Inc.e4P42015-07-15
00840663106325XenoSure Biologic PatchLemaitre Vascular, Inc.e4P62015-07-15
00840663106332XenoSure Biologic PatchLemaitre Vascular, Inc.e8P142015-07-15
00840663106349XenoSure Biologic PatchLemaitre Vascular, Inc.e10P162015-07-15
00840663106356XenoSure Biologic PatchLemaitre Vascular, Inc.e1P142015-07-15
00840663106806XenoSure Biologic PatchLemaitre Vascular, Inc.e6P82015-07-15
00840663107414XenoSure Biologic PatchLemaitre Vascular, Inc.e1.5P102015-07-15
09348992000587CardioCel Cardiovascular PatchADMEDUS REGEN PTY LTDUC02022020-04-16
09348992000600CardioCel Neo Cardiovascular PatchADMEDUS REGEN PTY LTDUC0404N2020-04-16
09348992000617CardioCel Cardiovascular PatchADMEDUS REGEN PTY LTDUC05082020-04-16
09348992000624CardioCel Neo Cardiovascular PatchADMEDUS REGEN PTY LTDUC0508N2020-04-16
09348992000631CardioCel Closure Cardiovascular PatchADMEDUS REGEN PTY LTDUC0614C2020-04-16
09348992000648CardioCel 3D Cardiovascular PatchADMEDUS REGEN PTY LTDUC0406A2020-04-16
09348992000655CardioCel 3D Cardiovascular PatchADMEDUS REGEN PTY LTDUC0405A302020-04-16
09348992000679VascuCel Vascular PatchADMEDUS REGEN PTY LTDUV08802020-04-16
09348992000686VascuCel Vascular PatchADMEDUS REGEN PTY LTDUV10142020-04-16
09348992000693VascuCel Vascular PatchADMEDUS REGEN PTY LTDUV20802020-04-16
00877234000560PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PFP8X142019-03-29
B040PFP6X81PhotoFixGENESEE BIOMEDICAL, INC.PFP6x82017-02-01
09348992000365CardioCelADMEDUS REGEN PTY LTDUC04042019-03-21
09348992000372CardioCelADMEDUS REGEN PTY LTDUC05082019-03-21
09348992000402CardioCel VSDADMEDUS REGEN PTY LTDUC02022019-03-21
09348992000440CardioCel NeoADMEDUS REGEN PTY LTDUC0404N2019-03-21
09348992000457CardioCel NeoADMEDUS REGEN PTY LTDUC0508N2019-03-21
09348992000488CardioCel ClosureADMEDUS REGEN PTY LTDUC0610C2019-03-21
09348992000495CardioCel ClosureADMEDUS REGEN PTY LTDUC0614C2019-03-21
09348992000525VascuCelADMEDUS REGEN PTY LTDUV08802019-03-21
09348992000532VascuCelADMEDUS REGEN PTY LTDUV20802019-03-21
09348992000549CardioCel 3DADMEDUS REGEN PTY LTDUC0406A2019-03-21
09348992000563VascuCelADMEDUS REGEN PTY LTDUV10142019-03-21
05037881003238Flouropassiv™VASCUTEK LTD921020FTS2015-10-22
05037881010410Gelseal™ Cardiovascular PatchVASCUTEK LTD9508042015-10-22
05037881010427Gelseal™ Cardiovascular PatchVASCUTEK LTD9510102015-10-22
05037881010434Gelseal™ Cardiovascular PatchVASCUTEK LTD9510202019-02-16
05037881010441Gelseal™ Cardiovascular PatchVASCUTEK LTD9512042015-10-22
05037881010458Gelseal™ Cardiovascular PatchVASCUTEK LTD9512082015-10-22
05037881010465Gelseal™ Cardiovascular PatchVASCUTEK LTD9512202019-02-18
05037881010618Gelsoft™ Cardiovascular PatchVASCUTEK LTD960501S2019-02-16
05037881010625Gelsoft™ Cardiovascular PatchVASCUTEK LTD9605012015-10-22
05037881010632Gelsoft™ Cardiovascular PatchVASCUTEK LTD9606032015-10-22
05037881010656Gelsoft™ Cardiovascular PatchVASCUTEK LTD9607012015-10-22
05037881010670Gelsoft™ Cardiovascular PatchVASCUTEK LTD9610012015-10-22
05037881010687Gelsoft™ Cardiovascular PatchVASCUTEK LTD9608042015-10-22
05037881010694Gelsoft™ Cardiovascular PatchVASCUTEK LTD9612042015-10-22
05037881010700Gelsoft™ Cardiovascular PatchVASCUTEK LTD9612082015-10-22
05037881010816ThinwallVASCUTEK LTD920675T2015-10-22
05037881010823ThinwallVASCUTEK LTD920875T2015-10-22
05037881010830ThinwallVASCUTEK LTD921050T2015-10-22
05037881010847ThinwallVASCUTEK LTD921075T2015-10-22
05037881010854ThinwallVASCUTEK LTD921010T2015-10-22
05037881010861ThinwallVASCUTEK LTD921550T2015-10-22
05037881010878ThinwallVASCUTEK LTD921575T2015-10-22
05037881010885ThinwallVASCUTEK LTD921015T2015-10-22
05037881010892ThinwallVASCUTEK LTD922512T2015-10-22
05037881011011Flouropassiv™VASCUTEK LTD920675FT2015-10-22
05037881011028Flouropassiv™VASCUTEK LTD920875FT2015-10-22
05037881011035Flouropassiv™VASCUTEK LTD921050FT2015-10-22
05037881011042Flouropassiv™VASCUTEK LTD921075FT2015-10-22
05037881011059Flouropassiv™VASCUTEK LTD921010FT2015-10-22
05037881011066Flouropassiv™VASCUTEK LTD921550FT2015-10-22
05037881011073Flouropassiv™VASCUTEK LTD921575FT2015-10-22
05037881011080Flouropassiv™VASCUTEK LTD920611FT2015-10-22
05037881011097Flouropassiv™VASCUTEK LTD921015FT2015-10-22
05037881011103Flouropassiv™VASCUTEK LTD922512FT2015-10-22
05037881999227ThinwallVASCUTEK LTD920675TS2015-10-22
05414734007252SJM™ST. JUDE MEDICAL, INC.C02052016-04-19