The following data is part of a premarket notification filed by Biocardia, Inc. with the FDA for Biocardia Morph Universal Deflectable Guide Catheter.
| Device ID | K042553 |
| 510k Number | K042553 |
| Device Name: | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | BIOCARDIA, INC. 384 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Contact | Daniel C Rosenman |
| Correspondent | Daniel C Rosenman BIOCARDIA, INC. 384 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2005-02-17 |
| Summary: | summary |