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510(k) K130889

SPLIT CATH RG by Medcomp — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 28, 2014
Date Received
March 29, 2013
Clearance Type
Traditional
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 Medcomp

  • K123292 — T3 (June 11, 2013)
  • K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (December 21, 2010)
  • K091954 — MICRO-STICK SET (January 8, 2010)
  • K091953 — PRO-PICC (September 16, 2009)
  • K092347 — PRO-PICC CT (September 16, 2009)
  • K090394 — VALVED TEARWAY INTRODUCER (September 1, 2009)
  • K091586 — VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN (July 23, 2009)
  • K091466 — 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 (June 17, 2009)
  • K081775 — THE MEDCOMP .010 VASCULAR GUIDEWIRES (March 25, 2009)
  • K081904 — PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (September 23, 2008)

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)