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510(k) K092797

ACUTE AND CHRONIC CATHETER REPAIR KIT by Kendall — Product Code NFK

K092797 is an FDA 510(k) premarket notification submitted by Kendall for the device "ACUTE AND CHRONIC CATHETER REPAIR KIT". The FDA issued a decision of Substantially Equivalent (kit) on November 19, 2009. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), 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 19, 2009
Date Received
September 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Hemodialysis Tray

Other clearances by Kendall

  • 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)
  • 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 NFK

  • K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 29, 2010)
  • K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (December 15, 2006)
  • K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (December 5, 2006)
  • K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 21, 2003)
  • K022644 — RETRO REPAIR KIT, MODEL PRRK5 (November 6, 2002)
  • K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK (October 31, 2002)
  • K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (August 23, 2002)
  • K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
  • K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (June 22, 2001)
  • K011576 — MEDCOMP ASH SPLIT (June 21, 2001)

FDA data resources