AUTOLOG AUTOTRANSFUSION SYSTEM

Apparatus, Autotransfusion

MEDTRONIC INC.

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

Pre-market Notification Details

Device IDK093535
510k NumberK093535
Device Name:AUTOLOG AUTOTRANSFUSION SYSTEM
ClassificationApparatus, Autotransfusion
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactCaralee Walton
CorrespondentCaralee Walton
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-16
Decision Date2010-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994667694 K093535 000
00613994667687 K093535 000
00613994667670 K093535 000
00613994520456 K093535 000
00643169751644 K093535 000
00643169266490 K093535 000
00643169201347 K093535 000

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