Medical Device Manufacturer · US , San Carlos , CA

Biocardia - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2020

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biocardia Cardiovascular ✕

2 devices

1-2 of 2

Cleared Aug 23, 2024

Morph DNA Steerable Introducer Sheath

Cardiovascular · 30d

Cleared Jan 07, 2020

BioCardia 8F Morph DNA Deflectable Guide Catheter

Cardiovascular · 99d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 11, 2026