Home / 510(k) Clearances / K113354

510(k) K113354

VETA PERITONEAL DIALYSIS CATHETER by Pfm Medical, Inc. — Product Code FJS

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 13, 2012
Date Received
November 14, 2011
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 Pfm Medical, Inc.

  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)
  • K241278 — ASEPT® Glide Peritoneal Drainage System (January 14, 2025)
  • K221779 — ASEPT Peritoneal Drainage System (May 2, 2023)
  • K213666 — NuCath Wedge Pressure Catheter (October 6, 2022)
  • K201137 — Asept Surgical Face Mask (August 19, 2020)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K140137 — SAFETY BIOPSY NEEDLE SYSTEM (March 25, 2014)
  • K122402 — LPP (LOW PROFILE PORT) (July 16, 2013)
  • K110914 — TRIPLE LUMEN PFM PICC (September 21, 2011)

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)
  • 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)
  • K031351 — FLEX-NECK PD CATHETER, INFANT (September 17, 2003)