APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

Oxygenator, Cardiopulmonary Bypass

DIDECO S.P.A.

The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Apex Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator.

Pre-market Notification Details

Device IDK020997
510k NumberK020997
Device Name:APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant DIDECO S.P.A. 195 WEST ST. Waltham,  MA  02451 -1163
ContactBarry Sall
CorrespondentBarry Sall
DIDECO S.P.A. 195 WEST ST. Waltham,  MA  02451 -1163
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-28
Decision Date2002-04-04
Summary:summary

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