Cleared Traditional

Percutaneous Introducer

K200624 · Epimed International, Inc. · Anesthesiology
Apr 2020
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K200624 is an FDA 510(k) clearance for the Percutaneous Introducer, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Epimed International, Inc. (Farmers Branch, US). The FDA issued a Cleared decision on April 27, 2020, 48 days after receiving the submission on March 10, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K200624 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2020
Decision Date April 27, 2020
Days to Decision 48 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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