> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# BioCardia Deflectable Guide Catheter Cleared
- URL: https://www.fdaweb.com/biocardia-deflectable-guide-catheter-cleared/
- Published: 2020-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:58:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145837

FDA has cleared a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The guide catheter is designed to improve procedural control of therapeutic catheters, such as the Helix system, during delivery of cell therapy, the company says. It provides bidirectional deflection, reduced torque build up or whip, enhanced fluoroscopic visibility, and improved ergonomics, it says. The device also features a new handle design with an adjustable brake for finer catheter control during procedures, it adds.