Catheter, Peritoneal Dialysis, Single Use

Device Code: 1906

Product Code(s): FKO

Device Classification Information

• Device Type ID: 1906
• Device Name: Catheter, Peritoneal Dialysis, Single Use
• Regulation Description: Peritoneal Dialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5630 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FKO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1906
• Device: Catheter, Peritoneal Dialysis, Single Use
• Product Code: FKO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Peritoneal Dialysis System And Accessories.
• CFR Regulation Number: 876.5630 [🔎]

Device Problems
Appropriate Term/Code Not Available	7
Total Device Problems	7

TPLC Last Update: 2019-04-02 20:01:44