Maquet Cardiovascular LLC

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 2242352, 3002707083
Owner Operator Numbers 10024202
Locations Covered LA CIOTAT Bouches-du-Rhone, FR; Wayne, NJ, US

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
1640201 Intervascular SAS LA CIOTAT Bouches-du-Rhone, FR Manufacture Medical Device View Details
2242352 Maquet Cardiovascular LLC Wayne, NJ, US Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0001-2014 Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart. Reason: MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades. 2013-09-20 Terminated View Details

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