Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

Catheter, Cannula And Tubing, Vascular, 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 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae.

Pre-market Notification Details

Device IDK162215
510k NumberK162215
Device Name:Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L 86, VIA STATALE 12 NORD Mirandola,  IT 41037
ContactLuigi Vecchi
CorrespondentScott Light
PAREXEL CONSULTING LLC 14401 W. 65TH WAY Arvada,  CO  80004 -3599
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-08
Decision Date2017-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178011991 K162215 000
38033178004788 K162215 000
38033178004856 K162215 000
38033178004962 K162215 000
38033178004979 K162215 000
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38033178011410 K162215 000
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38033178011458 K162215 000
38033178011472 K162215 000
38033178011496 K162215 000
38033178011861 K162215 000
38033178003897 K162215 000

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