Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

Oxygenator, Cardiopulmonary Bypass

Chalice Medical Ltd

The following data is part of a premarket notification filed by Chalice Medical Ltd with the FDA for Paragon Adult Maxi Pmp Oxygenator (model: Xcmop405pmp).

Pre-market Notification Details

Device IDK191246
510k NumberK191246
Device Name:Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Chalice Medical Ltd Manton Wood Enterprise Park, Worksop,  GB S80 2rs
ContactCarol Middleton
CorrespondentCarol Middleton
Chalice Medical Ltd Manton Wood Enterprise Park, Worksop,  GB S80 2rs
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-09
Decision Date2020-02-28

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