ATRICURE CRYO MODULE

Unit, Cryosurgical, Accessories

ATRICURE, INC.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Cryo Module.

Pre-market Notification Details

Device IDK111042
510k NumberK111042
Device Name:ATRICURE CRYO MODULE
ClassificationUnit, Cryosurgical, Accessories
Applicant ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester,  OH  45069
ContactRebecca Walters
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-04-15
Decision Date2011-05-26
Summary:summary

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