Home / 510(k) Clearances / K093546

510(k) K093546

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX by Togo Medikit Co., Ltd. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2009
Date Received
November 17, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Togo Medikit Co., Ltd.

  • K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 (September 17, 2024)
  • K200379 — Super Sheath (March 19, 2020)
  • K190001 — Supercath 5 (September 20, 2019)
  • K172496 — SUPERCATH 5 (26G) (March 23, 2018)
  • K160592 — SUPERCATH 6 (August 12, 2016)
  • K141070 — SUPER SHEATH (January 15, 2015)
  • K140419 — SUPERCATH5 (May 12, 2014)
  • K121504 — SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS (September 27, 2012)
  • K112290 — SUPERCATH Z3V (April 16, 2012)
  • K081953 — SUPERCATH 5 (March 12, 2009)

Other clearances for product code FOZ

  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (May 2, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)