Medical Device Manufacturer · US , Burlington , MA

Thoratec Corp - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2013

Recent clearances: CENTRIMAG PRIMARY CONSOLE (2ND GENERATION)

1
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1
Cleared
0
Denied

Thoratec Corp, specializes in cardiovascular medical devices, with a manufacturing facility in Burlington, US. The company is now part of Abbott, a global leader in cardiac and vascular technology solutions.

Thoratec has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity is historical, with its most recent clearance in 2013. All submissions focused on cardiovascular devices, reflecting the company's core expertise in heart failure and circulatory support technologies.

The cleared device, CENTRIMAG PRIMARY CONSOLE (2ND GENERATION), represents the company's work in mechanical circulatory support systems. Explore the device name, product code, and clearance date in the full 510(k) database record.

FDA 510(k) Regulatory Record - Thoratec Corp

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