# K200379: Super Sheath

- Pathway: 510(k) (Special)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Mar 19, 2020 after 30 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: 4 generations back to K954234 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141070: Super Sheath, Togo Medikit Co., Ltd. (2015) Summary page 5.

## 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/K200379
Methodology: https://510kreport.com/methodology