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510(k) K053123

PD CATH by Med-Conduit, Inc. — Product Code FJS

K053123 is an FDA 510(k) premarket notification submitted by Med-Conduit, Inc. for the device "PD CATH". The FDA issued a decision of Substantially Equivalent on March 29, 2006. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Med-Conduit, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2006
Date Received
November 7, 2005
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 Med-Conduit, Inc.

  • K062901 — HEMOCATH II (February 8, 2007)
  • K043292 — HEMOCATH (March 16, 2005)

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

FDA data resources