INTRAOPERATIVE BALLOON DILATION CATH.

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 Intraoperative Balloon Dilation Cath..

Pre-market Notification Details

Device IDK822393
510k NumberK822393
Device Name:INTRAOPERATIVE BALLOON DILATION CATH.
ClassificationCatheter, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-09
Decision Date1982-11-01

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