Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Maquet Cardiovascular, LLC · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
266 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC2026-04-272660
K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6Maquet Cardiovascular, LLC2025-05-30381
K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC2025-02-26680
K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6Maquet Cardiovascular, LLC2024-02-27810
K1919307 mm Extended Length EndoscopeMaquet Cardiovascular, LLC2020-04-152710
K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 ExtensiMaquet Cardiovascular, LLC2019-09-17570
K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC2016-04-191676
K153523FUSION Vascular GraftMaquet Cardiovascular, LLC2016-02-16690
K132743HARVESTING CANNULAMaquet Cardiovascular, LLC2013-12-03910
K131778FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFTMaquet Cardiovascular, LLC2013-11-141501
K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M0020217Maquet Cardiovascular, LLC2012-09-10140
K101274VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEMMaquet Cardiovascular, LLC2010-06-113610
K091733VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VHMaquet Cardiovascular, LLC2009-08-28781
K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLC2008-12-17911

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda