# K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port

- Pathway: 510(k) (Special)
- Applicant: Galt Medical
- Decided: Apr 12, 2012 after 237 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000313 (2000). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000313: Tearaway Introducer Sheath, Xentek Medical, Inc. (2000) Summary page 1.
- K043525: Catheter Introducer, Galt Medical Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K182660: GaltTWS (2019), 1 descendant of its own
- K170020: Peel-Away Introducer Set (2017), 1 descendant of its own

## Recalls of this device
- Jul 25, 2014 · Class II · Z-2588-2014: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
- Jul 25, 2014 · Class II · Z-2589-2014: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

## Indications for use
The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Source page: https://510kreport.com/device/K112398
Methodology: https://510kreport.com/methodology