Cleared Traditional

Introcan Safety 2 IV Catheter 18-24 gauge

K192676 · B.Braun Medical, Inc. · General Hospital
Apr 2020
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K192676 is an FDA 510(k) clearance for the Introcan Safety 2 IV Catheter 18-24 gauge, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on April 1, 2020, 188 days after receiving the submission on September 26, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K192676 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2019
Decision Date April 01, 2020
Days to Decision 188 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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