The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Coronary Angioscopic Catheter.
Device ID | K875108 |
510k Number | K875108 |
Device Name: | ACS CORONARY ANGIOSCOPIC CATHETER |
Classification | Angioscope |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Michael C Kolber |
Correspondent | Michael C Kolber ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | LYK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-14 |
Decision Date | 1988-09-27 |