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Wound Drain Catheter System

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4780
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4780 Powered suction pump

§ 878.4780 Powered suction pump.

(a) 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.

(b) Classification. Class II.

Wound Drain Catheter System

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4780
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4780 Powered suction pump

§ 878.4780 Powered suction pump.

(a) 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.

(b) Classification. Class II.