ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM

Catheter, Percutaneous

MEDTRONIC IRELAND

The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Attain Select Ii 6248del Delivery Catheter System.

Pre-market Notification Details

Device IDK053431
510k NumberK053431
Device Name:ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC IRELAND 1015 GRAMSIE ROAD Shoreview,  MN  55126
ContactMichelle Nivala
CorrespondentMichelle Nivala
MEDTRONIC IRELAND 1015 GRAMSIE ROAD Shoreview,  MN  55126
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-09
Decision Date2006-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994746887 K053431 000
00613994746832 K053431 000
00613994746801 K053431 000
00613994746627 K053431 000
00613994746610 K053431 000

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