AtriClip LAA Exclusion System With Preloaded 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 Pro·v Clip.

Pre-market Notification Details

Device IDK173031
510k NumberK173031
Device Name:AtriClip LAA Exclusion System With Preloaded PRO·V Clip
ClassificationClip, Implantable
Applicant AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
ContactMelissa Smallwood
CorrespondentMelissa Smallwood
AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-28
Decision Date2017-10-25
Summary:summary

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