ClearanceBrief
510(k) K954848 ยท MAL Graft, Vascular, Synthetic/Biologic Composite

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

ApplicantMeadox Medicals, Div. Boston Scientific Corp., Oakland NJ, US
DecisionSubstantially Equivalent - Subject to Tracking Reg., Feb 1, 1996
ReceivedOct 23, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K954848

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		 MALNone listed
Dec 1, 2021Maquet Cardiovascular, LLC
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Terminated		 MALNone listed
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		 MALNone listed
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		 MALNone listed
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		 MALNone listed
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Gold Woven and Knitted Double Vascular Grafts.
Terminated		 MALNone listed

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