TORQR SERIES DIAGNOSTIC EP CATHETERS

Catheter, Electrode Recording, Or Probe, Electrode Recording

CARDIORHYTHM

The following data is part of a premarket notification filed by Cardiorhythm with the FDA for Torqr Series Diagnostic Ep Catheters.

Pre-market Notification Details

Device IDK923915
510k NumberK923915
Device Name:TORQR SERIES DIAGNOSTIC EP CATHETERS
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose,  CA  95134
ContactGeorge M Savage
CorrespondentGeorge M Savage
CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose,  CA  95134
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-21
Decision Date1993-02-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00613994947413 K923915 000
00613994947406 K923915 000
00763000188535 K923915 000

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