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Sign in to claim this brandBiocardia, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 320 Soquel Way, Sunnyvale, CA, 94085
- Website
- biocardia.com
- —
- —
- [email protected]
- Phone
- 6502260120
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003610571
- DUNS Number
- 122370146
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Morph Universal Deflectable Guide Catheter | 00895 | FDA UDI | Class II | Active |
| Avance Steerable Introducer | AVA85-115-20 | FDA UDI | Class II | Active |
| Morph DNA | DNA55-115-30 | FDA UDI | Class II | Active |
| Morph AccessPro Steerable Introducer | MAP645 | FDA UDI | Class II | Active |
| Morph AccessPro Steerable Introducer | MAP690 | FDA UDI | Class II | Active |
| Avance Steerable Introducer | AVA85-115-30 | FDA UDI | Class II | Active |
| Helical Infusion Catheter | 00953L | FDA UDI | Class II | Active |
| Avance Steerable Catheter | AVA85-115-50 | FDA UDI | Class II | Active |
| BioCardia 8F Morph DNA Deflectable Guide Catheter | K192774 | FDA 510(k) | Class II | Active |
| Biocardia Morph Sheath Guide | K090999 | FDA 510(k) | Class II | Active |
| Biocardia Universal Deflectable Guide Catheter, Model 000664 | K012749 | FDA 510(k) | Class II | Active |
| Morph DNA Steerable Introducer Sheath | K242169 | FDA 510(k) | Class II | Active |
| BioCardia 8.5 F Avance Steerable lntroducer | K190941 | FDA 510(k) | Class II | Active |
| Biocardia Morph Universal Deflectable Guide Catheter | K042553 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 3, 2014 | Z-1302-2014 | — | terminated | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. |
| Mar 3, 2014 | Z-1301-2014 | — | terminated | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. |
| Feb 7, 2014 | Z-0991-2014 | — | terminated | Tyvek packaging may be worn, causing loss of package integrity. |