Cleared Traditional

UMBILI-CATH

K940870 · Gesco Intl., Inc. · General Hospital
Aug 1994
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K940870 is an FDA 510(k) clearance for the UMBILI-CATH, 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 August 2, 1994, 158 days after receiving the submission on February 25, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K940870 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1994
Decision Date August 02, 1994
Days to Decision 158 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FOS — Catheter, Umbilical Artery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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