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510(k) K991042

ASH ADVANTAGE PERITONEAL CATHETER by Janin Group, Inc. — Product Code FJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
March 29, 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 Janin Group, Inc.

  • K012502 — MEDIGROUP CATHETER EXTENDER/REPAIR KIT (February 4, 2002)
  • K013017 — MEDIGROUP KEY TUBE (December 6, 2001)
  • K970159 — FLEX-NECK PD CATHETER (September 5, 1997)
  • K810512 — MEDISEAL CAMERA COVERS (March 13, 1981)

Other clearances for product code FJS

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  • 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)