SUPERCATH 6— 510(k) K160592

Clearance details

Applicant

Togo Medikit Co., Ltd.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2016-03-01

Decision date

2016-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hyuga City, JP

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/10082024-09-17
• K200379 — Super Sheath2020-03-19
• K190001 — Supercath 52019-09-20
• K172496 — SUPERCATH 5 (26G)2018-03-23
• K141070 — SUPER SHEATH2015-01-15

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →