Cleared Traditional

CATCO SILICONE UMBILICAL VESSEL CATHETER

K944368 · Catco Medical, Inc. · General Hospital

Apr 1995

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K944368 is an FDA 510(k) clearance for the CATCO SILICONE UMBILICAL VESSEL CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 5, 1995, 210 days after receiving the submission on September 7, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K944368 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1994
Decision Date	April 05, 1995
Days to Decision	210 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200