OEI

Drainage Catheter With Antibiotic

Product code
OEI
Device name
Drainage Catheter With Antibiotic
Device class
Class 2
21 CFR
21 CFR 878.4780
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OEI
Classification and pathway per current FDA publications. Data from openFDA (CC0).