Panels › Cardiovascular › Product code MAL · Class 2
Graft, Vascular, Synthetic/Biologic Composite
Regulation 870.3450
0510(k)s in 12 months (6 all time)
0recalls in 12 months (49 all time)
46recalls that name a 510(k)
Top companies in MAL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Maquet Cardiovascular, LLC HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT-
D: 7 mm; L: 60 cm
Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Product Cod Terminated |
MAL | K954848 |
| Dec 1, 2021 | Maquet Cardiovascular, LLC Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 Terminated |
MAL | K954848 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | K021213 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | K052302 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | K052302 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal o Terminated |
MAL | K954848 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal o Terminated |
MAL | K954848 |
| Apr 7, 2020 | Maquet Cardiovascular, LLC Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal o Terminated |
MAL | K954848 |
| Aug 22, 2019 | GETINGE US SALES LLC The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascul Terminated |
MAL | K021213 |
| Jun 26, 2015 | Vascutek, Ltd. Gelseal Straight Diameter 8mm Length 30cm.
Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cere Terminated |
MAL | None listed |
| Jun 26, 2015 | Vascutek, Ltd. Gelseal Straight Diameter 8mm Length 15cm.
Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cere Terminated |
MAL | None listed |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 30x26
Catalog Number: ATC3026
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 30x24
Catalog Number: ATC3024
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 30x18
Catalog Number: ATC3018
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 30x16
Catalog Number: ATC3016
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 15x30
Catalog Number: ATC1530
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Woven with Collagen, Straight 15x26
Catalog Number: ATC1526
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 60x08
Catalog Number: AMC6008
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 60x07
Catalog Number: AMC6007
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 60x06
Catalog Number: AMC6006
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 40x08
Catalog Number: AMC4008
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 40x07
Catalog Number: AMC4007
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Bifurcate
20x10Catalog Number: AMC2010
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arterie Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Bifurcate 18x10
Catalog Number: AMC1810
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arterie Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Bifurcate 18x09
Catalog Number: AMC1809
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arterie Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. Albo Graft Knitted with Collagen, Bifurcate 16x08
Catalog Number: AMC1608
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteri Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Straight 15x06
Catalog Number: AMC1506
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteri Terminated |
MAL | K093231 K103080 |
| Jul 22, 2013 | LeMaitre Vascular, Inc. AlboGraft Knitted with Collagen, Bifurcate 14x08
Catalog Number: AMC1408
AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arterie Terminated |
MAL | K093231 K103080 |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Gold Woven and Knitted Double Vascular Grafts. Terminated |
MAL | K954848 |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Platinum Woven Double Velour TAAA Vascular Grafts. Terminated |
MAL | K052302 |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts. Terminated |
MAL | K021213 |
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