Cleared Traditional

Introcan Safety 3 Closed IV Catheter

K182870 · B.Braun Medical, Inc. · General Hospital
Mar 2019
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K182870 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 March 7, 2019, 146 days after receiving the submission on October 12, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K182870 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2018
Decision Date March 07, 2019
Days to Decision 146 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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