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U.S. Department of Health and Human Services

Product Classification

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Device peritoneal, drainage catheter for refractory ascites, long-term indwelling
Regulation Description Peritoneal dialysis system and accessories.
Definition For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Physical State Plastic tubing with a tissue ingrowth cuff and valve or connector.
Technical Method Typically attached to positive pressure or gravity feed to assist in drainage of fluid from the peritoneal cavity.
Target Area Peritoneal Cavity.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePNG
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 876.5630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible