SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011

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 Spherical Tip Coronary Ostial Cannula, Model 30011.

Pre-market Notification Details

Device IDK034058
510k NumberK034058
Device Name:SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactPreeti Jain
CorrespondentPreeti Jain
MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-30
Decision Date2004-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994737780 K034058 000

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