# K000313: Tearaway Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Xentek Medical, Inc.
- Decided: Jun 16, 2000 after 136 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043525: Catheter Introducer (2005), 15 descendants of its own
- K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port (2012), 11 descendants of its own
- K123430: Microslider Tearaway Introducer Set (2013), 5 descendants of its own
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (2016), 4 descendants of its own
- K152528: Attachable Cath Lab Hemostasis Valve (2015), 3 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-2197-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Source page: https://510kreport.com/device/K000313
Methodology: https://510kreport.com/methodology