Cleared Traditional

Medline Reinforced Epidural Catheter

K181782 · Medline Industries, Inc. · Anesthesiology
Mar 2019
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K181782 is an FDA 510(k) clearance for the Medline Reinforced Epidural Catheter, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on March 4, 2019, 244 days after receiving the submission on July 3, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K181782 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2018
Decision Date March 04, 2019
Days to Decision 244 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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