Cleared Traditional

K954015 - ABG POINT LOK NEEDLE PROTECTION DEVICE
(FDA 510(k) Clearance)

K954015 · Devon Industries, Inc. · Anesthesiology

Nov 1995

Decision

87d

Days

Class 1

Risk

K954015 is an FDA 510(k) clearance for the ABG POINT LOK NEEDLE PROTECTION DEVICE, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 20, 1995, 87 days after receiving the submission on August 25, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K954015 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 1995
Decision Date	November 20, 1995
Days to Decision	87 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.