# K043525: Catheter Introducer

- Pathway: 510(k) (Special)
- Applicant: Galt Medical Corp.
- Decided: Feb 9, 2005 after 50 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000313 (2000). 1 ancestor in all.
15 later devices descend from it; 5 cite it directly.
0 of 17 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.

## Most influential descendants
- 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
- K182660: GaltTWS (2019), 1 descendant of its own

## Recalls of this device
- Mar 27, 2025 · Class II · Z-1733-2025: Due to a potential open seal in the sterile barrier packaging .
- May 2, 2018 · Class II · Z-2562-2018: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate th
- May 2, 2018 · Class II · Z-2558-2018: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate th

## Indications for use
The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

Source page: https://510kreport.com/device/K043525
Methodology: https://510kreport.com/methodology