Cleared Special

CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

K121403 · Teleflex, Inc. · Anesthesiology

Jun 2012

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K121403 is an FDA 510(k) clearance for the CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Teleflex, Inc. (Reading, US). The FDA issued a Cleared decision on June 20, 2012, 41 days after receiving the submission on May 10, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K121403 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2012
Decision Date	June 20, 2012
Days to Decision	41 days
Submission Type	Special
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.