The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Naviport Deflectable Tip Guiding Catheter.
| Device ID | K974683 |
| 510k Number | K974683 |
| Device Name: | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Contact | Shelley Trimm |
| Correspondent | Shelley Trimm CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1999-06-22 |
| Summary: | summary |