Cleared Special

Introcan Safety IV Catheter

K220626 · B.Braun Medical, Inc. · General Hospital
May 2022
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K220626 is an FDA 510(k) clearance for the Introcan Safety 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 May 14, 2022, 71 days after receiving the submission on March 4, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K220626 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date May 14, 2022
Days to Decision 71 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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