Chase Medical, Inc. - FDA 510(k) Cleared Devices

Chase Medical, Inc. is a women-owned, small business medical device manufacturer dedicated to advanced cardiovascular surgery. Based in Richardson, Texas, the company specializes in state-of-the-art technologies for cardiac procedures, including beating heart surgery devices, surgical arms, and ventricular restoration systems.

The company has received 27 FDA 510(k) clearances from 27 total submissions between 1997 and 2004. Cardiovascular devices represent the dominant focus of Chase Medical's regulatory portfolio. The company is ISO 13485 certified and has maintained a perfect clearance record throughout its submission history.

Chase Medical's cleared device portfolio includes intracoronary shunts, retractors, mechanical stabilizers, vacuum stabilizers, surgical arms, and specialized catheters for coronary artery bypass and advanced cardiac interventions. The company's product line reflects over 25 years of experience in cardiac surgery innovation.

This company profile is maintained as a historical regulatory record. Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database.