# Maquet Cardiovascular, LLC

- Location (FDA's records): Wayne, NJ
- FDA decisions: 15 (1989–2026): 14 510(k) clearances and 1 original PMA approval
- Product codes: GEI (8), DSY (4), MAL (1), GBX (1), GCJ (1)
- 510(k) review time since 2016: median 75 days, against 111 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 24 (10 its own); citations of its devices by later devices: 14 (10 its own)
- Recalls linked to its devices: 21 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guidant Corp.: 6 (https://510kreport.com/company/guidant)
- Meadox Medicals, Div. Boston Scientific Corp.: 2 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Starion Instruments: 1 (https://510kreport.com/company/starion-instruments)
- Vescare, Inc.: 1 (https://510kreport.com/company/vescare)
- Dmc Medical, Ltd.: 1 (https://510kreport.com/company/dmc-medical)
- Dlp, Inc.: 1 (https://510kreport.com/company/dlp)

## Firms that cite its devices most
- Saphena Medical, Inc.: 1 (https://510kreport.com/company/saphena-medical)
- Meadox Medicals, Div. Boston Scientific Corp.: 1 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- Femasys, Inc.: 1 (https://510kreport.com/company/femasys)
- Moerae Matrix, Inc.: 1 (https://510kreport.com/company/moerae-matrix)

## Its most-cited devices
- K101274: Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (2010), cited by 3
- K082725: Graftguard Pressure Controlling Syringe (2008), cited by 3
- K131778: Fusion Vascular Graft and Fusion Bioline Vascular Graft (2013), cited by 2
- K233879: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (2024), cited by 2
- K091733: Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 (2009), cited by 2
- K153194: VASOVIEW HemoPro Endoscopic Vessel Harvesting System (2016), cited by 1

## Recent decisions
- K252445: Fusion Bioline Vascular Graft (Apr 27, 2026)
- K251238: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (May 30, 2025)
- K243918: Vasoview Hemopro 3 Power Supply (Feb 26, 2025)
- K233879: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (Feb 27, 2024)
- K191930: 7 mm Extended Length Endoscope (Apr 15, 2020)
- K191947: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord (Sep 17, 2019)
- K153194: VASOVIEW HemoPro Endoscopic Vessel Harvesting System (Apr 19, 2016)
- K153523: FUSION Vascular Graft (Feb 16, 2016)

Source page: https://510kreport.com/company/maquet-cardiovascular