DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO

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 Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, Dlp Retrograde Coronary Sinus Perfusio.

Pre-market Notification Details

Device IDK132995
510k NumberK132995
Device Name:DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactChelsea Pioske
CorrespondentChelsea Pioske
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-24
Decision Date2013-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169453177 K132995 000

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