Cordis Corp. - FDA 510(k) Cleared Devices

Cordis Corp., is a medical device manufacturer based in McHenry, US. The company specializes in interventional cardiovascular and gastroenterology devices.

Cordis has a substantial FDA 510(k) regulatory history spanning from 1976 to 2014. The company received 281 FDA 510(k) clearances from 315 total submissions. Its portfolio focuses primarily on cardiovascular devices and gastroenterology stent systems, including percutaneous transluminal angioplasty catheters, emboli capture guidewires, and self-expanding biliary stent systems. Notable cleared products include the FLEXSTENT Biliary Self Expanding Stent System, POWERFLEX PRO PTA Catheter, and SMART Nitinol Self-Expanding Stent.

The company is inactive in the FDA 510(k) clearance database, with no submissions recorded since 2014. This profile serves as a historical regulatory record of the company's device development and FDA clearance activity.

Explore the complete list of device names, product codes, and clearance dates in the database to review Cordis's full regulatory history.