Thoratec Corporation is one of 19596 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Thoratec Corporation - FDA 510(k) Cleared Devices
Recent clearances: Thoratec CentriMag Return (Arterial) Cannula Kit, Thoratec CentriMag Drainage (Venous) Cannula Kit
2
Total
2
Cleared
0
Denied
Thoratec Corporation, specializes in cardiovascular medical devices, with a manufacturing facility in Pleasanton, California. The company developed innovative technologies for cardiac support and circulatory assistance.
Thoratec received 2 FDA 510(k) clearances from 2 total submissions, with both clearances granted in 2015. All submissions focused on cardiovascular devices. The company's regulatory activity ended in 2015, making this a historical record of FDA clearance achievements.
The cleared devices included cannula kits designed for mechanical circulatory support systems, specifically for arterial return and venous drainage applications. These products supported critical care and heart failure treatment protocols.
Explore the complete device names, product codes, and clearance dates in the full 510(k) database record.
FDA 510(k) Regulatory Record - Thoratec Corporation
2 devices