AtriCure CryoICE Cryo-ablation Probe (Cryo2), AAtriCure CryoICE CryoSPHERE Cryoablation Probe (CryoS, CryoS-L)

Device, Surgical, Cryogenic

AtriCure Inc.

The following data is part of a premarket notification filed by Atricure Inc. with the FDA for Atricure Cryoice Cryo-ablation Probe (cryo2), Aatricure Cryoice Cryosphere Cryoablation Probe (cryos, Cryos-l).

Pre-market Notification Details

Device IDK200697
510k NumberK200697
Device Name:AtriCure CryoICE Cryo-ablation Probe (Cryo2), AAtriCure CryoICE CryoSPHERE Cryoablation Probe (CryoS, CryoS-L)
ClassificationDevice, Surgical, Cryogenic
Applicant AtriCure Inc. 7555 Innovation Way Mason,  OH  45040
ContactMelissa Smallwood
CorrespondentMelissa Smallwood
AtriCure Inc. 7555 Innovation Way Mason,  OH  45040
Product CodeGXH  
CFR Regulation Number882.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-17
Decision Date2020-12-23

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