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510(k) K871817

VAS-CATH PERITONEAL DIALYSIS CATHETER by Vas-Cath of Canada , Ltd. — Product Code FJS

K871817 is an FDA 510(k) premarket notification submitted by Vas-Cath of Canada , Ltd. for the device "VAS-CATH PERITONEAL DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Vas-Cath of Canada , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
May 11, 1987
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 Vas-Cath of Canada , Ltd.

  • K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C. (March 2, 1988)
  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K871488 — VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K853283 — VACCESS TM 4006 (August 22, 1985)
  • K844854 — OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT (May 21, 1985)
  • K844800 — OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS (May 16, 1985)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844336 — VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (March 13, 1985)
  • K844434 — VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (March 13, 1985)

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