MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC CARDIAC SURGICAL PRODUCTS

The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Medtronic Dlp Arterial Cannula With 3d Tip - 22 Fr..

Pre-market Notification Details

Device IDK013013
510k NumberK013013
Device Name:MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids,  MI  49504 -6393
ContactRoger W Brink
CorrespondentRoger W Brink
MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids,  MI  49504 -6393
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-07
Decision Date2001-12-04
Summary:summary

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