Device |
water, vascular access flush |
Regulation Description |
Intravascular catheter. |
Definition |
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use. |
Physical State |
Liquid |
Technical Method |
Physically occupies space within the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting |
Target Area |
vascular catheter |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | NZX |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5200
|
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 |
Not Third Party Eligible |