VERIPATH PERIPHERAL GUIDING CATHETER

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 Veripath Peripheral Guiding Catheter.

Pre-market Notification Details

Device IDK994229
510k NumberK994229
Device Name:VERIPATH PERIPHERAL GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
ContactStacey Simon
CorrespondentStacey Simon
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-16
Decision Date2000-02-25
Summary:summary

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