# K052557: Super Sheath Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Jan 17, 2006 after 123 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954234 (1995). 1 ancestor in all.
30 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954234: Radifocus Introducer II Kit, Terumo Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K060190: Super Sheath XL Introducer Sheath (2006), 13 descendants of its own
- 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
- K121504: Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets (2012), 9 descendants of its own

## Recalls of this device
- Nov 3, 2011 · Not classified · Z-0264-2012: Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product comp

## Indications for use
Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.

Source page: https://510kreport.com/device/K052557
Methodology: https://510kreport.com/methodology