LOW PROFILE STEERABLE-INTRAOPERATIVE

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-intraoperative.

Pre-market Notification Details

Device IDK833248
510k NumberK833248
Device Name:LOW PROFILE STEERABLE-INTRAOPERATIVE
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 Received1983-09-15
Decision Date1983-12-22

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