HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT— 510(k) K954848

Clearance details

Applicant

Meadox Medicals, Div. Boston Scientific Corp.

Product code

Code MAL

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

1995-10-23

Decision date

1996-02-01

Decision

Substantially Equivalent - Subject to Tracking Reg.

Clearance type

Traditional

Location

Oakland, NJ, 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
• K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS2002-04-19

• K953647 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING1997-05-16
• K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT1997-03-19
• K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT1997-03-17
• K961847 — HEMASHIELD VANTAGE (VASCULAR GRAFT1997-01-22
• K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH1996-09-10

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-0729-2022 — 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 Code/REF Number: M002020952070Class II·Terminated·Maquet Cardiovascular, LLC·20220114
• Z-0403-2022 — Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890Class II·Terminated·Maquet Cardiovascular, LLC·20211201
• Z-1859-2020 — 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 or occlusive disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1860-2020 — 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 or occlusive diseaseClass II·Terminated·Maquet Cardiovascular, LLC·20200407
• Z-1861-2020 — 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 or occlusive disease.Class II·Terminated·Maquet Cardiovascular, LLC·20200407

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954848.