| Device |
wound drain catheter system |
| Regulation Description |
Powered suction pump. |
| Definition |
For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures. |
| Physical State |
The system comprise of a silicone drainge tube, guide tube with integrated magnetic shuttle assembly. |
| Technical Method |
The system employs a magnetic clearance mechanism integrated into the drainage tubing to allow the user to clear materials which may accumulate inside the drainage tube. |
| Target Area |
For use in chest areas following thoracic surgical procedures. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OTK |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4780
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
|
Third Party Review
|
Accredited Persons
|
