The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Coronary Guiding Catheter-modified.
Device ID | K831563 |
510k Number | K831563 |
Device Name: | CORONARY GUIDING CATHETER-MODIFIED |
Classification | Catheter, Percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-16 |
Decision Date | 1983-06-30 |