TruFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Cath

Unit, Cryosurgical, Accessories

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Trufreeze Console, Pn Cc301; Aire Pv Passive Venting Catheter, Pn Co840703; 16 Fr Cdt 5 Pack, Pn 2000181; 20fr Cdt 5 Pack, Pn Acccc3cdt05; Active Venting Spray Kit, 20 Fr Cdt, Pn 2000177; Active Venting Spray Kit 16 Fr Cdt, Pn 20000516; Rapid Av Cath.

Pre-market Notification Details

Device IDK222272
510k NumberK222272
Device Name:TruFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Cath
ClassificationUnit, Cryosurgical, Accessories
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-08-18

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