Home / 510(k) Clearances / K970159

510(k) K970159

FLEX-NECK PD CATHETER by Janin Group, Inc. — Product Code FJS

K970159 is an FDA 510(k) premarket notification submitted by Janin Group, Inc. for the device "FLEX-NECK PD CATHETER". The FDA issued a decision of Substantially Equivalent on September 5, 1997. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Janin Group, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
January 16, 1997
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)
  • K991042 — ASH ADVANTAGE PERITONEAL CATHETER (June 25, 1999)
  • K810512 — MEDISEAL CAMERA COVERS (March 13, 1981)

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)

FDA data resources