SELECTIVE INFUSION II CATHETER

Catheter, Continuous Flush

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Selective Infusion Ii Catheter.

Pre-market Notification Details

Device IDK914751
510k NumberK914751
Device Name:SELECTIVE INFUSION II CATHETER
ClassificationCatheter, Continuous Flush
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
ContactJane E Beggs
CorrespondentJane E Beggs
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-22
Decision Date1993-05-24

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