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

Protaryx Medical, Inc. develops differentiated transseptal access devices for minimally invasive left heart interventional therapies. The company is based in Baltimore, Maryland, and focuses on streamlining workflow efficiency for catheter-based cardiac procedures.

The company has received 1 FDA 510(k) clearance from 1 total submission. Protaryx specializes in Cardiovascular devices, with its cleared device designed to facilitate transseptal access to the left atrium. The company achieved its first and latest clearance in 2026, demonstrating active regulatory engagement.

The cleared device features ZERO Exchange compatible delivery, high echogenicity, an extendable atraumatic positioning probe, and proprietary RF guidewire compatibility with standard electrosurgical generators. These design elements address key workflow and safety considerations in transseptal procedures.

Explore the company's FDA 510(k) clearance history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.