DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE

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 Dlp Silicone Coronary Artery Ostial Cannulae.

Pre-market Notification Details

Device IDK141951
510k NumberK141951
Device Name:DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactKevin T Lam
CorrespondentKevin T Lam
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-18
Decision Date2014-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169454594 K141951 000
20643169454600 K141951 000
20643169454587 K141951 000

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