Medical Device Manufacturer · US , San Jose , CA

Maquet Cardiovascular, LLC - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2008

Recent clearances: Fusion Bioline Vascular Graft, Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Power Supply

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Maquet Cardiovascular, LLC Cardiovascular ✕

4 devices

1-4 of 4

Cleared Apr 27, 2026

Fusion Bioline Vascular Graft

Cardiovascular · 266d

Cleared Feb 16, 2016

FUSION Vascular Graft

Cardiovascular · 69d

Cleared Nov 14, 2013

FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT

Cardiovascular · 150d

Cleared Sep 10, 2012

HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX

Cardiovascular · 14d