EOPA 3D Arterial Cannula

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 Eopa 3d Arterial Cannula.

Pre-market Notification Details

Device IDK150422
510k NumberK150422
Device Name:EOPA 3D Arterial Cannula
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 Northland Dr. Minneapolis,  MN  55428
ContactChelsea L Pioske
CorrespondentChelsea L Pioske
MEDTRONIC, INC. 7611 Northland Dr. Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-19
Decision Date2015-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20763000135700 K150422 000
20763000135694 K150422 000
20763000135526 K150422 000
20763000135502 K150422 000
20643169486250 K150422 000
20643169486243 K150422 000
00763000946852 K150422 000
00763000946845 K150422 000

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