Achieve ST Mapping Catheter, Catheter Connecting Cable

Catheter, Electrode Recording, Or Probe, Electrode Recording

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Achieve St Mapping Catheter, Catheter Connecting Cable.

Pre-market Notification Details

Device IDK153139
510k NumberK153139
Device Name:Achieve ST Mapping Catheter, Catheter Connecting Cable
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mail Stop MVS46 Mounds View,  MN  55112
ContactHeath Taylor
CorrespondentHeath Taylor
MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mail Stop MVS46 Mounds View,  MN  55112
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-30
Decision Date2016-05-06
Summary:summary

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