Cleared Traditional

DESERET(R) FLOW RESTRICTION VALVE

K914180 · Becton Dickinson Vascular Access, Inc. · General Hospital

May 1992

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K914180 is an FDA 510(k) clearance for the DESERET(R) FLOW RESTRICTION VALVE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on May 8, 1992, 233 days after receiving the submission on September 18, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K914180 FDA.gov
FDA Decision	Cleared SEKD
Date Received	September 18, 1991
Decision Date	May 08, 1992
Days to Decision	233 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