The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Brachial Coronary Guiding Catheter.
| Device ID | K822862 |
| 510k Number | K822862 |
| Device Name: | BRACHIAL CORONARY GUIDING CATHETER |
| 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 | 1982-09-27 |
| Decision Date | 1982-10-18 |