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U.S. Department of Health and Human Services

Product Classification

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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 CodePEH
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible