DLP CORONARY OSTIAL PERFUSION 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 Coronary Ostial Perfusion Cannulae.

Pre-market Notification Details

Device IDK131269
510k NumberK131269
Device Name:DLP CORONARY OSTIAL PERFUSION 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 Received2013-05-03
Decision Date2013-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994576044 K131269 000
20613994575955 K131269 000
20613994575962 K131269 000
20613994575979 K131269 000
20613994575986 K131269 000
20613994575993 K131269 000
20613994576006 K131269 000
20613994576013 K131269 000
20613994576020 K131269 000
20613994576037 K131269 000
20613994575948 K131269 000

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