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510(k) K854773

SUPERCATH A.V. FISTULA by Togo Medikit Co., Ltd. — Product Code FIE

K854773 is an FDA 510(k) premarket notification submitted by Togo Medikit Co., Ltd. for the device "SUPERCATH A.V. FISTULA". The FDA issued a decision of Substantially Equivalent on April 8, 1986. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Togo Medikit Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1986
Date Received
November 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
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)
  • K093546 — SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX (December 17, 2009)

Other clearances for product code FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)

FDA data resources