# K060190: Super Sheath XL Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Apr 4, 2006 after 70 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: 2 generations back to K954234 (1995). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 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 2.

## Most influential descendants
- K091006: Itg Vascular Access System, Model 300 (2010), 12 descendants of its own
- K100615: Arstasis Access System (2010), 11 descendants of its own
- K102728: Arstasis Access System (2010), 10 descendants of its own
- K103143: Arstasis One Latchwire Access System (2011), 9 descendants of its own
- K113110: Axera Access System (2011), 8 descendants of its own

## Indications for use
The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

Source page: https://510kreport.com/device/K060190
Methodology: https://510kreport.com/methodology