Cleared Traditional

K833091 - DESERET SUBCLAVIAN JUGULAR CATH-SET
(FDA 510(k) Clearance)

K833091 · Warner-Lambert Co. · General Hospital

Nov 1983

Decision

70d

Days

Class 2

Risk

K833091 is an FDA 510(k) clearance for the DESERET SUBCLAVIAN JUGULAR CATH-SET, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983, 70 days after receiving the submission on September 12, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K833091 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1983
Decision Date	November 21, 1983
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

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