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)
Top companies in DSY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DSY | K992960 |
| Mar 10, 2023 | Maquet Cardiovascular, LLC Fusion Bioline Vascular Graft, Part number M00201503046B0 Open, Classified |
DSY | K131778 |
| Apr 29, 2022 | Maquet 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 |
DSY | K984294 |
| Aug 25, 2021 | Atrium 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 |
DSY | K992960 |
| Jul 8, 2021 | Vascutek, 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 |
DSY | K013022 K034010 +2 |
| May 12, 2021 | W 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 |
DSY | K062161 |
| May 12, 2021 | W 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 |
DSY | K062161 |
| Feb 9, 2016 | Bard 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 |
DSY | K983861 |
| Feb 9, 2016 | Bard 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 |
DSY | K983861 |
| Aug 18, 2014 | Vascutek, Ltd. Gelweave (TM) Vascular Prostheses
Manufactured by - VASCUTEK Ltd
a TERUMO company Terminated |
DSY | None listed |
| Nov 18, 2013 | Terumo 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 |
DSY | K990503 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta SST Grafts <6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K010516 K020767 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta SST Grafts <6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K010517 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta VS Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K992443 |
| Sep 30, 2013 | Atrium 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 |
DSY | K071923 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta SST Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K010516 |
| Sep 30, 2013 | Atrium Medical Corporation Flixene Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K060124 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta SST Bifurcated Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K020767 |
| Sep 30, 2013 | Atrium Medical Corporation Flixene IFG with Assisted Delivery
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K122138 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta SuperSoft Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K000499 |
| Sep 30, 2013 | Atrium Medical Corporation Flixene IFG Vascular Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K051332 |
| Sep 30, 2013 | Atrium Medical Corporation Advanta VXT Vascular Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | K992960 |
| Mar 7, 2011 | Maquet 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 |
DSY | K962342 |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Gold Woven Double Velour Vascular Branch Graft Terminated |
DSY | K012952 |
| May 14, 2010 | Maquet 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 |
DSY | K052964 |
| May 14, 2010 | Maquet 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 |
DSY | K052964 |
| Apr 28, 2010 | Intervascular 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 |
DSY | K964625 |
| Apr 23, 2010 | Intervascular 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 |
DSY | K964625 |
| Feb 26, 2010 | Maquet 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 |
DSY | K052964 |
| Sep 28, 2005 | Boston Scientific Corporation Hemashield Vantage Vascular Graft. Vascular graft prosthesis. Terminated |
DSY | K961847 |
| Jul 20, 2004 | Datascope 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 |
DSY | K983819 |
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