ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

Catheter, Percutaneous

MEDTRONIC IRELAND

The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Attain Command+surevalve Left Heart Delivery System Attain Command Guide Catheters For Left Heart Delivery,attain Select.

Pre-market Notification Details

Device IDK123153
510k NumberK123153
Device Name:ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC IRELAND PARKMORE BUSINESS PARK WEST Galway,  IE El
ContactDeirdre Mcmahon
CorrespondentDeirdre Mcmahon
MEDTRONIC IRELAND PARKMORE BUSINESS PARK WEST Galway,  IE El
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-09
Decision Date2013-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169143289 K123153 000
00643169142893 K123153 000
00643169142886 K123153 000
00643169142879 K123153 000
00643169142862 K123153 000
00643169142855 K123153 000
00643169142848 K123153 000
00643169142831 K123153 000
00643169184190 K123153 000
00643169184183 K123153 000
00643169142909 K123153 000
00643169142916 K123153 000
00643169143272 K123153 000
00643169143265 K123153 000
00643169143258 K123153 000
00643169143210 K123153 000
00643169143203 K123153 000
00643169143197 K123153 000
00643169143180 K123153 000
00643169143173 K123153 000
00643169143081 K123153 000
00643169184176 K123153 000

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