ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE

Catheter, Electrode Recording, Or Probe, Electrode Recording

MEDTRONIC ABLATION FRONTIERS, LLC

The following data is part of a premarket notification filed by Medtronic Ablation Frontiers, Llc with the FDA for Achieve Mapping Catheter And Electrical Cable.

Pre-market Notification Details

Device IDK102588
510k NumberK102588
Device Name:ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MEDTRONIC ABLATION FRONTIERS, LLC 2210 FARADAY AVENUE SUIT 100 Carlsbad,  CA  92008
ContactBrenda Clay
CorrespondentBrenda Clay
MEDTRONIC ABLATION FRONTIERS, LLC 2210 FARADAY AVENUE SUIT 100 Carlsbad,  CA  92008
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-09
Decision Date2011-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994763907 K102588 000
00643169504516 K102588 000
00643169489097 K102588 000
00643169489080 K102588 000
00643169467385 K102588 000
00643169467378 K102588 000
00643169345560 K102588 000

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