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510(k) K062671

14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) by Kendall — Product Code MSD

K062671 is an FDA 510(k) premarket notification submitted by Kendall for the device "14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)". The FDA issued a decision of Substantially Equivalent (kit) on November 3, 2006. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Kendall has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 3, 2006
Date Received
September 8, 2006
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)
  • 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)
  • K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (October 6, 2005)
  • 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

  • K241581 — Hemodialysis Catheter (May 16, 2025)
  • K210461 — End Cap (September 14, 2021)
  • 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)

FDA data resources