MODIFICATION TO ACS CORONARY GUIDING

Igm (mu Chain Specific), Antigen, Antiserum, Control

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK841992
510k NumberK841992
Device Name:MODIFICATION TO ACS CORONARY GUIDING
ClassificationIgm (mu Chain Specific), Antigen, Antiserum, Control
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDAO  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-25
Decision Date1984-06-11

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