SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS— 510(k) K121504

Name: FDA 510(k) clearance K121504
Creator: U.S. Food and Drug Administration
Published: 2012-09-27

Substantially Equivalent

Togo Medikit Co., Ltd.

FDA 510(k) clearance K121504 for SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS, Substantially Equivalent on 2012-09-27. Applicant: Togo Medikit Co., Ltd.. Device class: 2.

Clearance details

Applicant: Togo Medikit Co., Ltd.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2012-05-21
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05

More clearances from Togo Medikit Co., Ltd.

view all

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
K160592 — SUPERCATH 62016-08-12

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.