ATRICURE TRANSPOLAR SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

ATRICURE, INC.

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

Pre-market Notification Details

Device IDK052893
510k NumberK052893
Device Name:ATRICURE TRANSPOLAR SYSTEM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester,  OH  45069
ContactElsa Chi Abruzzo
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-10-14
Decision Date2005-10-25
Summary:summary

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