FDA.report

Cardiovascular patch, animal-derived

Definition
An 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
90
Last updated
2025-06-05 07:53:03

Related Product Codes

CodeDeviceSpecialtyClassDevices
FTMMesh, SurgicalGeneral, Plastic Surgery244
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular223
PSQIntracardiac Patch Or Pledget, Biologically DerivedCardiovascular219
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular24

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00850038226008InvengenxTisgenx, Inc.XM-042025-05-28
00850038226015InvengenxTisgenx, Inc.XM-052025-05-28
00850038226022InvengenxTisgenx, Inc.XM-05T2025-05-28
00850038226039InvengenxTisgenx, Inc.XM-062025-05-28
00850038226046InvengenxTisgenx, Inc.XM-072025-05-28
00850038226053InvengenxTisgenx, Inc.XM-07T2025-05-28
00850038226060InvengenxTisgenx, Inc.XM-082025-05-28
00850038226077InvengenxTisgenx, Inc.XM-08T2025-05-28
00850038226084InvengenxTisgenx, Inc.XM-092025-05-28
00850038226091InvengenxTisgenx, Inc.XM-102025-05-28
00850038226107InvengenxTisgenx, Inc.XM-10T2025-05-28
00850038226114InvengenxTisgenx, Inc.XM-112025-05-28
00850038226121InvengenxTisgenx, Inc.XM-122025-05-28
00850038226138InvengenxTisgenx, Inc.XM-132025-05-28
00850038226145InvengenxTisgenx, Inc.XM-142025-05-28
00850038226152InvengenxTisgenx, Inc.XM-152025-05-28
00850038226169InvengenxTisgenx, Inc.XM-162025-05-28
00850038226176InvengenxTisgenx, Inc.XM-172025-05-28
00850038226183InvengenxTisgenx, Inc.XM-182025-05-28
00850038226190InvengenxTisgenx, Inc.XM-192025-05-28
00850038226206InvengenxTisgenx, Inc.XM-202025-05-28
00850038226213InvengenxTisgenx, Inc.XM-212025-05-28
00850038226220InvengenxTisgenx, Inc.XM-222025-05-28
00850038226237InvengenxTisgenx, Inc.XM-232025-05-28
00840663110551CardioCel Bioscaffold Patch 4 cm X 4 cmLemaitre Vascular, Inc.UC04042024-10-10
00840663110568CardioCel Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.UC05082024-10-10
00840663110575CardioCel Bioscaffold Patch 6 cm X 14 cmLemaitre Vascular, Inc.UC0614C2024-10-10
00840663110605CardioCel Neo Bioscaffold Patch 4 cm X 4 cm Lemaitre Vascular, Inc.UC0404N2024-10-10
00840663110667VascuCel Bioscaffold Patch .8 cm X 8 cmLemaitre Vascular, Inc.UV08802024-10-10
00840663110674VascuCel Bioscaffold Patch 1 cm X 14 cmLemaitre Vascular, Inc.UV10142024-10-10
00840663110773CardioCel Neo Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.UC0508N2024-10-10
00840663110544CardioCel Bioscaffold Patch 2 cm X 2 cmLemaitre Vascular, Inc.UC02022024-10-08
00859389005331EluPro Antibiotic-Eluting BioEnvelopeAZIYO BIOLOGICS, INC.CMCV-124-MED2024-09-06
00859389005348EluPro Antibiotic-Eluting BioEnvelopeAZIYO BIOLOGICS, INC.CMCV-124-LRG2024-09-06
00850023375087CardiaMendHelios Cardio Inc.CMUS-05NS-05062023-07-07
00384401007661Hemapatch KnittedINTERVASCULAR SASHEK10/140P (1)2023-03-30
00384401010654Hemapatch KnittedINTERVASCULAR SASHEK20/140P (1)2023-03-30
00384401011224Hemacarotid PatchINTERVASCULAR SASHEK10/150CPUT (1)2023-03-27
00384401011248Hemacarotid PatchINTERVASCULAR SASHEK25/100CPUT (1)2023-03-27
00085412818474Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG01062022-11-28
00085412818498Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG01082022-11-28
00085412818511Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG01102022-11-28
00085412818535Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG01142022-11-28
00085412818559Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG015102022-11-28
00085412818573Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG02092022-11-28
00085412818634Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.VG025152022-11-28
00850023375001CardiaMendHelios Cardio Inc.CMUS-10NS-06122022-02-01
00850023375018CardiaMendHelios Cardio Inc.CMUS-10NS-08162022-02-01
00850023375025CardiaMendHelios Cardio Inc.CMUS-10NS-05062022-02-01
00850023375032CardiaMendHelios Cardio Inc.CMUS-10NS-10152022-02-01
00850023375049CardiaMendHelios Cardio Inc.CMUS-05NS-08122022-02-01
00850023375056CardiaMendHelios Cardio Inc.CMUS-05NS-04072022-02-01
00840663108718XenoSure Biologic PatchLemaitre Vascular, Inc.12P252021-06-18
00840663108787XenoSure Biologic PatchLemaitre Vascular, Inc.2.5BV152021-06-18
00840663108794XenoSure Biologic PatchLemaitre Vascular, Inc.5BV102021-06-18
00840663108800XenoSure Biologic PatchLemaitre Vascular, Inc.12BV252021-06-18
00840663108824XenoSure Biologic PatchLemaitre Vascular, Inc.e5P102021-06-18
00840663108831XenoSure Biologic PatchLemaitre Vascular, Inc.e2.5P152021-06-18
00840663109210XenoSure Thick Biologic PatchLemaitre Vascular, Inc.e6P8T2021-06-18
00840663109227XenoSure Thick Biologic PatchLemaitre Vascular, Inc.e10P16T2021-06-18
00840663109333XenoSure Biologic PledgetsLemaitre Vascular, Inc.PL0307R252021-06-18
00840663109340XenoSure Biologic PledgetsLemaitre Vascular, Inc.PL0506R252021-06-18
00840663109357XenoSure Biologic PledgetsLemaitre Vascular, Inc.PL0510R252021-06-18
00840663108695XenoSure Biologic PatchLEMAITRE VASCULAR, INC.2.5P152021-02-26
00840663108701XenoSure Biologic PatchLEMAITRE VASCULAR, INC.5P102021-02-26
09348992000006CardioCelADMEDUS REGEN PTY LTDUC02022015-09-17
09348992000013CardioCelADMEDUS REGEN PTY LTDUC04042015-09-17
09348992000020CardioCelADMEDUS REGEN PTY LTDUC05082015-09-17
09348992000037CardioCel ADMEDUS REGEN PTY LTDUC06142015-09-17
09348992000082CardioCelADMEDUS REGEN PTY LTDUC02082015-09-17
09348992000105CardioCel VSDADMEDUS REGEN PTY LTDUC02022016-07-13
09348992000143CardioCel NeoADMEDUS REGEN PTY LTDUC0404N2016-10-17
09348992000150CardioCel NeoADMEDUS REGEN PTY LTDUC0508N2016-10-17
09348992000181CardioCel AgileADMEDUS REGEN PTY LTDUC0404A2016-10-17
09348992000198CardioCel AgileADMEDUS REGEN PTY LTDUC0508A2016-10-17
09348992000228CardioCel ClosureADMEDUS REGEN PTY LTDUC0610C2016-10-17
09348992000235CardioCel ClosureADMEDUS REGEN PTY LTDUC0614C2016-10-17
09348992000266VascuCelADMEDUS REGEN PTY LTDUV08802016-10-21
09348992000273VascuCelADMEDUS REGEN PTY LTDUV20802016-10-21
09348992000280CardioCel 3DADMEDUS REGEN PTY LTDUC0406A2017-05-09