ClearanceBrief
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)
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Top companies in MAL

DateFirm and productCodeLinked 510(k)
Jan 14, 2022Maquet 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
MALK954848
Dec 1, 2021Maquet Cardiovascular, LLC
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Terminated
MALK954848
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALNone listed
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK021213
Apr 7, 2020Maquet 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
MALK052302
Apr 7, 2020Maquet 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
MALK052302
Apr 7, 2020Maquet 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
MALK954848
Apr 7, 2020Maquet 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
MALK954848
Apr 7, 2020Maquet 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
MALK954848
Aug 22, 2019GETINGE 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
MALK021213
Jun 26, 2015Vascutek, 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
MALNone listed
Jun 26, 2015Vascutek, 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
MALNone listed
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2013LeMaitre 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
MALK093231
K103080
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Gold Woven and Knitted Double Vascular Grafts.
Terminated
MALK954848
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.
Terminated
MALK052302
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.
Terminated
MALK021213

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