Cleared Traditional

ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER

K122027 · Arrow International, Inc. · Anesthesiology

Aug 2012

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K122027 is an FDA 510(k) clearance for the ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on August 28, 2012, 48 days after receiving the submission on July 11, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K122027 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2012
Decision Date	August 28, 2012
Days to Decision	48 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.