OEI · Drainage Catheter With Antibiotic
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | OEI |
|---|---|
| Device Name | Drainage Catheter With Antibiotic |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | Bacterin International, Inc. | Nov 28, 2007 | SESE |
Top Applicants
- Bacterin International, Inc. — 1 clearance
