RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Retrograde Coronary Sinus Perfusion Cannula With No Pressure Line (15 French, Manual And Auto Inflate).

Pre-market Notification Details

Device IDK030696
510k NumberK030696
Device Name:RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis,  MN  55428
ContactPreeti Jain
CorrespondentPreeti Jain
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-06
Decision Date2003-04-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169087037 K030696 000
20613994457299 K030696 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.