# K141070: Super Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Jan 15, 2015 after 265 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052557: Super Sheath Introducer Sheath, Togo Medikit Co., Ltd. (2006) Summary page 5.
- K121504: Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets, Togo Medikit Co., Ltd. (2012) Summary page 5.

## Most influential descendants
- K200379: Super Sheath (2020), 0 descendants of its own

## Indications for use
The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K141070
Methodology: https://510kreport.com/methodology