Cleared Traditional

K023140 - VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
(FDA 510(k) Clearance)

K023140 · Epimed International, Inc. · Anesthesiology

Aug 2003

Decision

329d

Days

Class 2

Risk

K023140 is an FDA 510(k) clearance for the VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 15, 2003, 329 days after receiving the submission on September 20, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number	K023140 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2002
Decision Date	August 15, 2003
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF