The following data is part of a premarket notification filed by Biocardia, Inc. with the FDA for Biocardia 8.5 F Avance Steerable Lntroducer.
| Device ID | K190941 |
| 510k Number | K190941 |
| Device Name: | BioCardia 8.5 F Avance Steerable Lntroducer |
| Classification | Introducer, Catheter |
| Applicant | BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos, CA 94070 |
| Contact | Kevin Demartini |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007221027 | K190941 | 000 |
| 00850007221010 | K190941 | 000 |
| 00850007221003 | K190941 | 000 |