510(k) Report

FDA applicant

Maquet Cardiovascular, LLC

Wayne, NJ15 decisions1989–202621 recalls

FDA records 15 decisions for Maquet Cardiovascular, LLC (Wayne, NJ) from 1989 to 2026: 14 510(k) clearances and 1 original PMA approval. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 10 of them its own earlier devices. 21 recalls are linked to its devices, 3 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Maquet Cardiovascular, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 12009: 12010: 12012: 12013: 22016: 22019: 12020: 12024: 12025: 22026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 12017: 12022: 22023: 62024: 7, 3 Class I2025: 32026 (partial year): 1
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Maquet Cardiovascular, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maquet Cardiovascular, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories8decisions
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter4decisions
  • MALGraft, Vascular, Synthetic/Biologic Composite1decision
  • GBXCatheter, Irrigation1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 75 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 20103cite it
  • K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 20083cite it
  • K131778Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 20132cite it
  • K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel…Maquet Cardiovascular, LLC · 20242cite it
  • K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 20092cite it
  • K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 20161cites it

What has FDA decided for it lately?

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel…Maquet Cardiovascular, LLC · 20251 recall
  • K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025
  • K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel…Maquet Cardiovascular, LLC · 2024
  • K1919307 mm Extended Length EndoscopeMaquet Cardiovascular, LLC · 2020
  • K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed…Maquet Cardiovascular, LLC · 2019
  • K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 20161 Class I recall
  • K153523FUSION Vascular GraftMaquet Cardiovascular, LLC · 2016

All 15 as Maquet Cardiovascular, LLC →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K101274The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI…Jun 2, 2026Class II
  • K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW…Aug 6, 2025Class II
  • K101274The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in…Mar 20, 2025Class II
  • K101274Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the…Mar 10, 2025Class II
  • K101274VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000.…Dec 9, 2024Class I
  • K101274Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers…Dec 9, 2024Class I

Other applicant names beginning “Maquet”

FDA records each applicant name separately; these may or may not be the same firm.

Maquet Cardiopulmonary, AG 44Maquet Critical Care AB 20Maquet GmbH 8Maquet Critica Care AB 1Maquet GmbH (A Getinge Group Company) 1