# K241230: Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Sep 17, 2024 after 138 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954234 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121504: Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets, Togo Medikit Co., Ltd. (2012) Summary page 5.

## Indications for use
The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

Source page: https://510kreport.com/device/K241230
Methodology: https://510kreport.com/methodology