LOW PROFILE STEERABLE BALLOON DILATA

Catheter, Angioplasty, Peripheral, Transluminal

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Low Profile Steerable Balloon Dilata.

Pre-market Notification Details

Device IDK831403
510k NumberK831403
Device Name:LOW PROFILE STEERABLE BALLOON DILATA
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-02
Decision Date1983-06-08

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