OTK · Wound Drain Catheter System
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | OTK |
|---|---|
| Device Name | Wound Drain Catheter System |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc. | Mar 2, 2021 | SESE |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | Jul 26, 2019 | SESE |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | Aug 14, 2018 | SESE |
| K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | Nov 30, 2016 | SESE |
| K153681 | PleuraFlow System | Clearflow, Inc. | Jan 20, 2016 | SESE |
| K150042 | PleuraFlow System | Clearflow, Inc. | Jun 2, 2015 | SESE |
| K093565 | PLEURAFLOW CATHETER SYSTEM | Clear Catheter Systems | Dec 3, 2010 | SESE |
Top Applicants
- Clearflow, Inc. — 6 clearances
- Clear Catheter Systems — 1 clearance
