DLP Vein Graft 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 Dlp Vein Graft Cannula.

Pre-market Notification Details

Device IDK143107
510k NumberK143107
Device Name:DLP Vein Graft Cannula
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
ContactKevin Lam
CorrespondentKevin Lam
MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-29
Decision Date2015-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169881321 K143107 000

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