The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Cardima Tracker(r) Infusion Catheter.
| Device ID | K932800 |
| 510k Number | K932800 |
| Device Name: | CARDIMA TRACKER(R) INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | CARDIMA, INC. 47201 LAKEVIEW BLVD. Fremont, CA 94537 -5120 |
| Contact | Michael E Klicpera |
| Correspondent | Michael E Klicpera CARDIMA, INC. 47201 LAKEVIEW BLVD. Fremont, CA 94537 -5120 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-12-21 |