Cleared Special

Introcan Safety 3 Closed IV Catheter

K213085 · B.Braun Medical, Inc. · General Hospital
Oct 2021
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K213085 is an FDA 510(k) clearance for the Introcan Safety 3 Closed 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. (Allentown, US). The FDA issued a Cleared decision on October 25, 2021, 31 days after receiving the submission on September 24, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K213085 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2021
Decision Date October 25, 2021
Days to Decision 31 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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