DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF

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 Single Stage Venous Cannula Inflatable Cuff.

Pre-market Notification Details

Device IDK120987
510k NumberK120987
Device Name:DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactEmily Blus
CorrespondentEmily Blus
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-02
Decision Date2012-06-06
Summary:summary

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