# K152528: Attachable Cath Lab Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Dec 2, 2015 after 90 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000313 (2000). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990975: IN-Line Hemostasis Valve, Merit Medical Systems, Inc. (2000) Summary page 4.
- K043525: Catheter Introducer, Galt Medical Corp. (2005) Summary page 4.
- K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port, Galt Medical (2012) Summary page 4.

## Most influential descendants
- K182660: GaltTWS (2019), 1 descendant of its own
- K220280: Arrow Stiffening Stylet (2022), 0 descendants of its own
- K173287: Elite HV Radial (2017), 0 descendants of its own

## Indications for use
The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

Source page: https://510kreport.com/device/K152528
Methodology: https://510kreport.com/methodology