The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Cardima Seeker And Stubbie Guidewires.
| Device ID | K932801 |
| 510k Number | K932801 |
| Device Name: | CARDIMA SEEKER AND STUBBIE GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIMA, INC. 47201 LAKEVIEW BLVD. Fremont, CA 94537 -5120 |
| Contact | Michael E Klicepra |
| Correspondent | Michael E Klicepra CARDIMA, INC. 47201 LAKEVIEW BLVD. Fremont, CA 94537 -5120 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-09-01 |