Cleared Traditional

K061250 - MULTICATH EXPERT
(FDA 510(k) Clearance)

K061250 · Vygon Corp. · General Hospital

Sep 2006

Decision

148d

Days

Class 2

Risk

K061250 is an FDA 510(k) clearance for the MULTICATH EXPERT. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ).

Submitted by Vygon Corp. (Norristown, US). The FDA issued a Cleared decision on September 29, 2006, 148 days after receiving the submission on May 4, 2006.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K061250 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2006
Decision Date	September 29, 2006
Days to Decision	148 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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