MADTRONIC DLP ARTERIAL CANNULAE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Madtronic Dlp Arterial Cannulae.

Pre-market Notification Details

Device IDK991066
510k NumberK991066
Device Name:MADTRONIC DLP ARTERIAL CANNULAE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 620 WATSON,SW P.O.BOX 409 Grand Rapids,  MI  49501
ContactJames Balun
CorrespondentJames Balun
MEDTRONIC VASCULAR 620 WATSON,SW P.O.BOX 409 Grand Rapids,  MI  49501
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-31
Decision Date1999-09-14
Summary:summary

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