MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB

Console, Heart-lung Machine, Cardiopulmonary Bypass

RAND S.R.L.

The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Medtronic Performer Tm Cpb, Model R51, Pcpb.

Pre-market Notification Details

Device IDK052555
510k NumberK052555
Device Name:MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactPreeti Jain
CorrespondentPreeti Jain
RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-16
Decision Date2006-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994160638 K052555 000
00885074514857 K052555 000

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