Cleared Traditional

I.V. CATHETER SYSTEM

K980493 · Johnson & Johnson Medical, Inc. · General Hospital
Apr 1998
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K980493 is an FDA 510(k) clearance for the I.V. CATHETER SYSTEM, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on April 28, 1998, 78 days after receiving the submission on February 9, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K980493 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1998
Decision Date April 28, 1998
Days to Decision 78 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

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