MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS— 510(k) K021213

Clearance details

Applicant

Boston Scientific Corp

Product code

Code MAL

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

2002-04-17

Decision date

2002-04-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Natick,, MA, US

• K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX2012-09-10
• K103080 — ALBOGRAFT VASCULAR PROSTHESIS2011-01-19
• K093231 — ALBOGRAFT VASCULAR PROSTHESIS2010-01-14
• K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION2005-09-12
• K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT1996-02-01

• K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more2024-10-18
• K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)2023-08-19
• K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary2015-11-20
• K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System2015-08-05
• K150303 — XXL Vascular Balloon Dilatation Catheter2015-06-15

Death

4

Total

4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1864-2020 — 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 occlusive disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1865-2020 — 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 occlusive disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1866-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1867-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1868-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1869-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1870-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1871-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1873-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1874-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1875-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1876-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1877-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1878-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1879-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1880-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1881-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1882-2020 — 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 disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-2559-2019 — 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 Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.Class II·Terminated·GETINGE US SALES LLC·20190822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021213.