Cleared Special

STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK

K030937 · Arrow International, Inc. · Anesthesiology
Apr 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K030937 is an FDA 510(k) clearance for the STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK, 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 April 23, 2003, 29 days after receiving the submission on March 25, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K030937 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2003
Decision Date April 23, 2003
Days to Decision 29 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.