PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

Oxygenator, Cardiopulmonary Bypass

DIDECO S.R.L.

The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for Performa Adult Hollow Fiber Membrane Oxygenator.

Pre-market Notification Details

Device IDK050447
510k NumberK050447
Device Name:PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant DIDECO S.R.L. 195 WEST ST. Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
DIDECO S.R.L. 195 WEST ST. Waltham,  MA  02451
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-22
Decision Date2005-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178100718 K050447 000
38033178100688 K050447 000

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