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510(k) K993149

PERITONEAL DIALYSIS CATHETERS AND ADAPTERS by Medionics International, Inc. — Product Code FJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2000
Date Received
September 21, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal, Long-Term Indwelling
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medionics International, Inc.

  • K130441 — FALLER STYLET (April 19, 2013)
  • K994218 — EASY CARE AND TUBING SETS (February 10, 2000)
  • K945567 — QC CAP (February 7, 1995)
  • K910173 — SELECTRA AND TUBING SETS (January 13, 1992)
  • K883393 — CAPD DISPOSABLE Y SYSTEM - DY SET (November 3, 1988)
  • K842305 — C.A.P.D. AUTOMATIC HEATER PDH 200 (June 25, 1984)
  • K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER (October 14, 1983)
  • K831766 — MICROSTAR VCI (October 14, 1983)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

Other clearances for product code FJS

  • K213602 — Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter (January 14, 2022)
  • K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialy (July 27, 2018)
  • K130441 — FALLER STYLET (April 19, 2013)
  • K121383 — PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMP (September 5, 2012)
  • K120130 — FALLER TROCAR (May 21, 2012)
  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)
  • K071167 — FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (August 31, 2007)
  • K070730 — FLEX-NECK ARC CATHETER (July 3, 2007)
  • K060897 — EMBEDDING TOOL, MODEL TE-1000 (July 18, 2006)
  • K053123 — PD CATH (March 29, 2006)