The following data is part of a premarket notification filed by Biocardia, Inc. with the FDA for Biocardia Universal Deflectable Guide Catheter, Model 000664.
| Device ID | K012749 |
| 510k Number | K012749 |
| Device Name: | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOCARDIA, INC. 384 OYSTER POINT BLVD. #6 South San Francisco, CA 94080 |
| Contact | Daniel C Rosenman |
| Correspondent | Daniel C Rosenman BIOCARDIA, INC. 384 OYSTER POINT BLVD. #6 South San Francisco, CA 94080 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2002-01-24 |
| Summary: | summary |