The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Advanced Cardiovascular-coronary Guid.
Device ID | K842195 |
510k Number | K842195 |
Device Name: | ADVANCED CARDIOVASCULAR-CORONARY GUID |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-04 |
Decision Date | 1984-07-13 |