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510(k) K950042

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER by Accurate Surgical Instruments Co. — Product Code FJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1995
Date Received
January 5, 1995
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 Accurate Surgical Instruments Co.

  • K920515 — INSERTION (May 4, 1992)
  • K910786 — TROCAR (FALLER STYLET) (September 19, 1991)
  • K910785 — TITANIUM CATHETER EXTENDER (August 22, 1991)
  • K910787 — TITANIUM CONNECTOR (2 PART) (August 15, 1991)
  • K862046 — SWAN-NECK PERITONEAL DIALYSIS CATHETERS (June 19, 1986)
  • K850214 — STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN (July 26, 1985)
  • K813487 — CATHETER BUBBLE STAND (December 31, 1981)
  • K813488 — CATHETER REGULAR (December 31, 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)