ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY

Catheter, Percutaneous

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain 6218a-am Amplatz Guide Catheter For Left-heart Delivery.

Pre-market Notification Details

Device IDK024035
510k NumberK024035
Device Name:ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
ContactLynn Jensen
CorrespondentLynn Jensen
MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-06
Decision Date2002-12-30

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