Cleared Traditional

Arrow Epidural Catheter Kit

K161075 · Teleflexmedical, Inc. · Anesthesiology

Oct 2016

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K161075 is an FDA 510(k) clearance for the Arrow Epidural Catheter Kit, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 4, 2016, 169 days after receiving the submission on April 18, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K161075 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2016
Decision Date	October 04, 2016
Days to Decision	169 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.