Cleared Traditional

SECURE ARTERIAL BLOOD SAMPLING SYSTEM

K070340 · Smiths Medical Asd, Inc. · Anesthesiology

Mar 2007

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K070340 is an FDA 510(k) clearance for the SECURE ARTERIAL BLOOD SAMPLING SYSTEM, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Smiths Medical Asd, Inc. (Dublin, US). The FDA issued a Cleared decision on March 15, 2007, 37 days after receiving the submission on February 6, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K070340 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2007
Decision Date	March 15, 2007
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBT — Arterial Blood Sampling Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 868.1100
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.