ClearanceBrief
Panels › Cardiovascular › Product code DSY · Class 2

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Regulation 870.3450

1510(k)s in 12 months (188 all time)
2recalls in 12 months (87 all time)
86recalls that name a 510(k)
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Top companies in DSY

DateFirm and productCodeLinked 510(k)
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Jun 4, 2024Atrium Medical Corporation
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Open, Classified
DSYK992960
Mar 10, 2023Maquet Cardiovascular, LLC
Fusion Bioline Vascular Graft, Part number M00201503046B0
Open, Classified
DSYK131778
Apr 29, 2022Maquet Cardiovascular, LLC
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and b
Terminated
DSYK984294
Aug 25, 2021Atrium Medical Corporation
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK992960
Jul 8, 2021Vascutek, Ltd.
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular graft
Terminated
DSYK013022
K034010 +2
May 12, 2021W L Gore & Associates, Inc.
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI:
Open, Classified
DSYK062161
May 12, 2021W L Gore & Associates, Inc.
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI:
Open, Classified
DSYK062161
Feb 9, 2016Bard Peripheral Vascular Inc
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Terminated
DSYK983861
Feb 9, 2016Bard Peripheral Vascular Inc
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Terminated
DSYK983861
Aug 18, 2014Vascutek, Ltd.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Terminated
DSYNone listed
Nov 18, 2013Terumo Cardiovascular Systems Corporation
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Len
Terminated
DSYK990503
Sep 30, 2013Atrium Medical Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK010516
K020767
Sep 30, 2013Atrium Medical Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK010517
Sep 30, 2013Atrium Medical Corporation
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK992443
Sep 30, 2013Atrium Medical Corporation
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK071923
Sep 30, 2013Atrium Medical Corporation
Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK010516
Sep 30, 2013Atrium Medical Corporation
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK060124
Sep 30, 2013Atrium Medical Corporation
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK020767
Sep 30, 2013Atrium Medical Corporation
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK122138
Sep 30, 2013Atrium Medical Corporation
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK000499
Sep 30, 2013Atrium Medical Corporation
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK051332
Sep 30, 2013Atrium Medical Corporation
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated
DSYK992960
Mar 7, 2011Maquet Cardiovascular, LLC
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to,
Terminated
DSYK962342
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Gold Woven Double Velour Vascular Branch Graft
Terminated
DSYK012952
May 14, 2010Maquet Cardiovascular, LLC
EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripher
Terminated
DSYK052964
May 14, 2010Maquet Cardiovascular, LLC
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace perip
Terminated
DSYK052964
Apr 28, 2010Intervascular S.A.S.
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
Terminated
DSYK964625
Apr 23, 2010Intervascular S.A.S.
InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneur
Terminated
DSYK964625
Feb 26, 2010Maquet Cardiovascular, LLC
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
Terminated
DSYK052964
Sep 28, 2005Boston Scientific Corporation
Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
Terminated
DSYK961847
Jul 20, 2004Datascope Corporation
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/
Terminated
DSYK983819

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