Cleared Traditional

Arrow Epidural Catheter Kit

K143581 · Teleflexmedical, Inc. · Anesthesiology
Jun 2015
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K143581 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 June 26, 2015, 190 days after receiving the submission on December 18, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K143581 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2014
Decision Date June 26, 2015
Days to Decision 190 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.