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510(k) K200379

Super Sheath by Togo Medikit Co., Ltd. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2020
Date Received
February 18, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
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)
  • 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)
  • K093546 — SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX (December 17, 2009)
  • K081953 — SUPERCATH 5 (March 12, 2009)

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  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)