PLATINUM SERIES EP DIAGNOSTIC CATHETERS

Catheter, Electrode Recording, Or Probe, Electrode Recording

MEDTRONIC CARDIORHYTHM

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

Pre-market Notification Details

Device IDK953185
510k NumberK953185
Device Name:PLATINUM SERIES EP DIAGNOSTIC CATHETERS
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MEDTRONIC CARDIORHYTHM 130 RIO ROBLES San Jose,  CA  95134 -1806
ContactKeith V Rohrbach
CorrespondentKeith V Rohrbach
MEDTRONIC CARDIORHYTHM 130 RIO ROBLES San Jose,  CA  95134 -1806
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-10
Decision Date1996-04-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169139602 K953185 000
00643169139596 K953185 000
00643169139558 K953185 000
00643169139541 K953185 000
00643169139534 K953185 000
00643169139510 K953185 000
00643169139503 K953185 000

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