The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Coronary Guiding Catheter.
| Device ID | K830829 |
| 510k Number | K830829 |
| Device Name: | CORONARY GUIDING CATHETER |
| Classification | Introducer, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-04-28 |