Cleared Special

Introcan Safety 2 IV Catheter

K220756 · B.Braun Medical, Inc. · General Hospital
Jun 2022
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K220756 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. (Allentown, US). The FDA issued a Cleared decision on June 23, 2022, 100 days after receiving the submission on March 15, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K220756 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2022
Decision Date June 23, 2022
Days to Decision 100 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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