Paragon Adult Maxi PMP Oxygenator With Tubing Pack

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 With Tubing Pack.

Pre-market Notification Details

Device IDK201642
510k NumberK201642
Device Name:Paragon Adult Maxi PMP Oxygenator With Tubing Pack
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Chalice Medical Ltd Manton Wood Enterprise Park Worksop,  GB S80 2rs
ContactStephen Horan
CorrespondentStephen Horan
Chalice Medical Ltd Manton Wood Enterprise Park Worksop,  GB S80 2rs
Product CodeDTZ  
Subsequent Product CodeDTR
Subsequent Product CodeDWF
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-17
Decision Date2020-09-18

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