Biocardia
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest FDA decision2024-08-23
SEC Filings: 1 filings on record. Latest: 8-K (2026-08-12). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K242169 | Morph DNA Steerable Introducer Sheath | DYB | 2024-08-23 | View |
| 510(k) | K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | DQY | 2020-01-07 | View |
No matching devices.