Cleared Traditional

K950303 - DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
(FDA 510(k) Clearance)

K950303 · Becton Dickinson Vascular Access, Inc. · General Hospital

Mar 1995

Decision

48d

Days

Class 2

Risk

K950303 is an FDA 510(k) clearance for the DESERET(R) I.V. LOOP AND DESERET (R) J LOOP, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on March 14, 1995, 48 days after receiving the submission on January 25, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K950303 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 1995
Decision Date	March 14, 1995
Days to Decision	48 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF