The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Urethan Coronary Guiding Catheter.
| Device ID | K904884 |
| 510k Number | K904884 |
| Device Name: | ACS URETHAN CORONARY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-26 |
| Decision Date | 1991-01-03 |