MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT

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 Medtronic Clear Intravacular Arteriotomy Shunt.

Pre-market Notification Details

Device IDK120612
510k NumberK120612
Device Name:MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
ContactKelley Breheim
CorrespondentKelley Breheim
MEDTRONIC INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-29
Decision Date2012-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885074257464 K120612 000
00885074257457 K120612 000
00885074257440 K120612 000
00885074257433 K120612 000
00885074257426 K120612 000
00885074257419 K120612 000
00885074257402 K120612 000
00885074257112 K120612 000

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