ClearanceBrief
510(k) K021213 ยท MAL Graft, Vascular, Synthetic/Biologic Composite

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

ApplicantBoston Scientific Corp, Natick, MA, US
DecisionSubstantially Equivalent, Apr 19, 2002
ReceivedApr 17, 2002
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K021213

DateFirm and productCodeLinked 510(k)
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
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
MALNone listed
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.
Terminated
MALNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.