Cleared Traditional

K940952 - UMBILI-CATH-S-DL
(FDA 510(k) Clearance)

K940952 · Gesco Intl., Inc. · General Hospital

Jul 1994

Decision

150d

Days

Class 2

Risk

K940952 is an FDA 510(k) clearance for the UMBILI-CATH-S-DL, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on July 29, 1994, 150 days after receiving the submission on March 1, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K940952 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1994
Decision Date	July 29, 1994
Days to Decision	150 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement