Cleared Traditional

CENTURION UMBILICAL CATHETER

K942353 · Tri-State Hospital Supply Corp. · General Hospital
Aug 1995
Decision
455d
Days
Class 2
Risk

About This 510(k) Submission

K942353 is an FDA 510(k) clearance for the CENTURION UMBILICAL CATHETER, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on August 15, 1995, 455 days after receiving the submission on May 17, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K942353 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1994
Decision Date August 15, 1995
Days to Decision 455 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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