BALLOON DILATION CATHETER

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 Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK843501
510k NumberK843501
Device Name:BALLOON DILATION CATHETER
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 Received1984-09-06
Decision Date1984-10-04

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