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 |