APEX HP M 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 Adult Hollow Fiber Membrane Oxygenator.

Pre-market Notification Details

Device IDK092895
510k NumberK092895
Device Name:APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham,  MA  02451
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-21
Decision Date2009-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178109919 K092895 000

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