XVAC

Apparatus, Autotransfusion

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 Xvac.

Pre-market Notification Details

Device IDK110782
510k NumberK110782
Device Name:XVAC
ClassificationApparatus, Autotransfusion
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 CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-21
Decision Date2011-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817753070 K110782 000

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