Cleared Special

Introcan Safety? 2 IV Catheter

K241845 · B.Braun Medical, Inc. · General Hospital
Jul 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241845 is an FDA 510(k) clearance for the Introcan Safety? 2 IV Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 26, 2024, 30 days after receiving the submission on June 26, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K241845 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2024
Decision Date July 26, 2024
Days to Decision 30 days
Submission Type Special
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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