AutoLog IQ Autotransfusion System

Apparatus, Autotransfusion

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Autolog Iq Autotransfusion System.

Pre-market Notification Details

Device IDK181954
510k NumberK181954
Device Name:AutoLog IQ Autotransfusion System
ClassificationApparatus, Autotransfusion
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 Northland Drive Brooklyn Park,  MN  55428
ContactSue Fidler
CorrespondentSue Fidler
MEDTRONIC PERFUSION SYSTEMS 7611 Northland Drive Brooklyn Park,  MN  55428
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-23
Decision Date2018-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169982864 K181954 000
00763000057503 K181954 000
00763000057480 K181954 000

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