AnastoClip GC Closure System

Clip, Implantable

LeMaitre Vascular, Inc.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Anastoclip Gc Closure System.

Pre-market Notification Details

Device IDK173323
510k NumberK173323
Device Name:AnastoClip GC Closure System
ClassificationClip, Implantable
Applicant LeMaitre Vascular, Inc. 63 Second Ave. Burlington,  MA  01803
ContactXiang Zhang
CorrespondentXiang Zhang
LeMaitre Vascular, Inc. 63 Second Ave. Burlington,  MA  01803
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-20
Decision Date2018-03-08
Summary:summary

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