ACS CORONARY ANGIOSCOPIC CATHETER

Angioscope

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Coronary Angioscopic Catheter.

Pre-market Notification Details

Device IDK875108
510k NumberK875108
Device Name:ACS CORONARY ANGIOSCOPIC CATHETER
ClassificationAngioscope
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMichael C Kolber
CorrespondentMichael C Kolber
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeLYK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-14
Decision Date1988-09-27

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