The following data is part of a premarket notification filed by Biocardia with the FDA for Biocardia 8f Morph Dna Deflectable Guide Catheter.
| Device ID | K192774 |
| 510k Number | K192774 |
| Device Name: | BioCardia 8F Morph DNA Deflectable Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | BioCardia 125 Shoreway Road, Suite B San Carlos, CA 94070 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee BioCardia 125 Shoreway Road, Suite B San Carlos, CA 94070 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866749000295 | K192774 | 000 |