The following data is part of a premarket notification filed by Biocardia, Inc. with the FDA for Biocardia Morph Sheath Guide.
| Device ID | K090999 |
| 510k Number | K090999 |
| Device Name: | BIOCARDIA MORPH SHEATH GUIDE |
| Classification | Introducer, Catheter |
| Applicant | BIOCARDIA, INC. 125 SHOREWAY ROAD, SUITE B San Carlos, CA 94070 |
| Contact | David Snow |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-08 |
| Decision Date | 2009-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866749000257 | K090999 | 000 |
| 00866749000240 | K090999 | 000 |