The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Modification To Acs Coronary Guiding.
| Device ID | K841992 |
| 510k Number | K841992 |
| Device Name: | MODIFICATION TO ACS CORONARY GUIDING |
| Classification | Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | DAO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-25 |
| Decision Date | 1984-06-11 |