CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE

Wire, Guide, Catheter

CARDIOMETRICS, INC.

The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Accutrac Intravascular Guide Wire.

Pre-market Notification Details

Device IDK952562
510k NumberK952562
Device Name:CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactMichael J Billig
CorrespondentMichael J Billig
CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-02
Decision Date1995-08-29

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