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510(k) K241230

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 by Togo Medikit Co., Ltd. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
May 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Togo Medikit Co., Ltd.

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  • 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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