Cleared Traditional

Arrow 0.2 Micron Flat Filter, GVS

K222341 · Arrow International, LLC · Anesthesiology

Feb 2023

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K222341 is an FDA 510(k) clearance for the Arrow 0.2 Micron Flat Filter, GVS, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Arrow International, LLC (Morrisville, US). The FDA issued a Cleared decision on February 13, 2023, 194 days after receiving the submission on August 3, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K222341 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2022
Decision Date	February 13, 2023
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.