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

Oxygenator, Cardiopulmonary Bypass

SORIN GROUP ITALIA S.R.L.

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Apex Hp M Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator.

Pre-market Notification Details

Device IDK083021
510k NumberK083021
Device Name:APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham,  MA  02451
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-09
Decision Date2008-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178109926 K083021 000
38033178109902 K083021 000

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