Cleared Traditional

KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT

K941493 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology

Jun 1994

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K941493 is an FDA 510(k) clearance for the KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on June 22, 1994, 86 days after receiving the submission on March 28, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K941493 FDA.gov
FDA Decision	Cleared SEKD
Date Received	March 28, 1994
Decision Date	June 22, 1994
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

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.