CARDIOMETRICS DUALFLOW SWITCH BOX

Wire, Guide, Catheter

CARDIOMETRICS, INC.

The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Dualflow Switch Box.

Pre-market Notification Details

Device IDK940984
510k NumberK940984
Device Name:CARDIOMETRICS DUALFLOW SWITCH BOX
ClassificationWire, Guide, Catheter
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactSusan E Osborne
CorrespondentSusan E Osborne
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 Received1994-03-01
Decision Date1994-08-18

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