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510(k) K051584

14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY by Kendall — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2005
Date Received
June 15, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Kendall

  • K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT (November 19, 2009)
  • K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATE (November 3, 2006)
  • K061936 — KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 (August 9, 2006)
  • K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALIND (August 4, 2006)
  • K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (January 6, 2006)
  • K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (December 22, 2004)
  • K042461 — KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (December 10, 2004)
  • K042572 — KENDALL CO2NFIRM NOW CO2 DETECTOR (November 5, 2004)
  • K041914 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (September 27, 2004)
  • K041006 — TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR (May 19, 2004)

Other clearances for product code MSD

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  • K203575 — GlidePath Retro Long-Term Hemodialysis Catheter (July 1, 2021)
  • K211410 — GlidePath 13F Long-Term Hemodialysis Catheter (June 4, 2021)
  • K203767 — Pristine Long-Term Hemodialysis Catheter (April 2, 2021)
  • K202150 — GlidePath 7.5F Long-Term Dialysis Catheter (November 18, 2020)
  • K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (September 3, 2020)
  • K200627 — GlidePath 10F Long-Term Dialysis Catheter (June 22, 2020)
  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 2020)
  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)