The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter.
| Device ID | K973298 |
| 510k Number | K973298 |
| Device Name: | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION 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 | 1997-09-02 |
| Decision Date | 1998-06-26 |
| Summary: | summary |