AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove PRO V Clip

Clip, Implantable

Atricure, Inc.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Pro V Clip.

Pre-market Notification Details

Device IDK153500
510k NumberK153500
Device Name:AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove PRO V Clip
ClassificationClip, Implantable
Applicant Atricure, Inc. 6217 Centre Park Drive West Chester,  OH  45069
ContactJonathan Mcelwee
CorrespondentJonathan Mcelwee
Atricure, Inc. 6217 Centre Park Drive West Chester,  OH  45069
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-07
Decision Date2016-01-27
Summary:summary

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