MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Miar (minimally Invasive Aortic Root) Cannula With Flow-guard, Models 11012l And 11014l.

Pre-market Notification Details

Device IDK100274
510k NumberK100274
Device Name:MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactCaralee Walton
CorrespondentCaralee Walton
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-29
Decision Date2010-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994495499 K100274 000
20613994495468 K100274 000

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