Cleared Special

AtriClip FLEX-V

K180010 · AtriCure, Inc. · General & Plastic Surgery
Jan 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K180010 is an FDA 510(k) clearance for the AtriClip FLEX-V, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on January 31, 2018, 29 days after receiving the submission on January 2, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K180010 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2018
Decision Date January 31, 2018
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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