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 |