OEI · Class II · 21 CFR 878.4780

FDA Product Code OEI: Drainage Catheter With Antibiotic

A Tubular Drain Made From Silicone Or Similar Material And Is Coated With A Silver Containing Material And Is Intended To Drain Fluids From Body Cavities Using Gravity Drainage Or Attached To A Suction Pump.

Leading manufacturers include Bacterin International, Inc..

Total

Cleared

398d

Avg days

2007

Since

FDA 510(k) Cleared Drainage Catheter With Antibiotic Devices (Product Code OEI)

1 devices

1–1 of 1

Cleared Nov 28, 2007

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

K063245

Bacterin International, Inc.

General & Plastic Surgery · 398d

About Product Code OEI - Regulatory Context

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Data Source

FDA 510(k) public files . 176,325 total devices indexed.

Latest clearance: Nov 28, 2007

Product Code Info

Code	OEI
Device class	Class II
CFR	21 CFR 878.4780
Panel	General & Plastic Surgery

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