ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP

Catheter, Percutaneous

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Coronary Guiding Catheter W/soft Tip.

Pre-market Notification Details

Device IDK874874
510k NumberK874874
Device Name:ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
ClassificationCatheter, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMarianna Faist
CorrespondentMarianna Faist
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-27
Decision Date1988-02-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.