Cleared Traditional

Perifix FX Catheter; Contiplex FX Catheter

K231242 · B.Braun Medical, Inc. · Anesthesiology
Sep 2023
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K231242 is an FDA 510(k) clearance for the Perifix FX Catheter; Contiplex FX Catheter, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2023, 137 days after receiving the submission on May 1, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K231242 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2023
Decision Date September 15, 2023
Days to Decision 137 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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