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# Cagent Vascular Serranator Balloon Catheter Cleared
- URL: https://www.fdaweb.com/cagent-vascular-serranator-balloon-catheter-cleared/
- Published: 2020-04-23T12:00:00.000Z
- Updated: 2026-09-14T16:12:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146640

FDA has cleared a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The device uses the company’s serration technology in a semi-compliant balloon for treating peripheral artery disease, the company says. It is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion, it adds. The company also recently completed enrollment in its PRELUDE-BTK trial, a multi-center feasibility study to show the safety and efficacy of the device and will include 30-day and six-month follow up.