Cleared Traditional

B. Braun Tear-Away Introducer Needle

K171584 · B.Braun Medical, Inc. · Anesthesiology
Dec 2017
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K171584 is an FDA 510(k) clearance for the B. Braun Tear-Away Introducer Needle, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on December 22, 2017, 205 days after receiving the submission on May 31, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K171584 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2017
Decision Date December 22, 2017
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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