Cleared Traditional

FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER

K103658 · Teleflex, Inc. · Anesthesiology

May 2012

Decision

518d

Days

Class 2

Risk

About This 510(k) Submission

K103658 is an FDA 510(k) clearance for the FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Teleflex, Inc. (Reading, US). The FDA issued a Cleared decision on May 16, 2012, 518 days after receiving the submission on December 15, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K103658 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2010
Decision Date	May 16, 2012
Days to Decision	518 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.