Device |
hemodialysis catheter luer end cap |
Regulation Description |
Blood access device and accessories. |
Definition |
For use in hemodialysis catheters to reduce hub infection. |
Physical State |
Plastic end cap with rod attached |
Technical Method |
Antimicrobial agent adhered to rod and lock ring of end cap. End cap has a rod which extends into the hub of the hemodialysis catheter to aid in delivering antimicrobial agent |
Target Area |
Implanted blood access device |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | PEH |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5540
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |