AMG PMP Pediatric

Oxygenator, Cardiopulmonary Bypass

Eurosets S.r.l.

The following data is part of a premarket notification filed by Eurosets S.r.l. with the FDA for Amg Pmp Pediatric.

Pre-market Notification Details

Device IDK202206
510k NumberK202206
Device Name:AMG PMP Pediatric
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Eurosets S.r.l. Strada Statale 12, N°143 Medolla,  IT I-41036
ContactKatia Vescovini
CorrespondentKatia Vescovini
Eurosets S.r.l. Strada Statale 12, N°143 Medolla,  IT I-41036
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-05
Decision Date2021-04-01

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