# K173287: Elite HV Radial

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Dec 21, 2017 after 66 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: 5 generations back to K954234 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152173: Glidesheath, Terumo Medical Corporation (2015) Summary page 4.
- K043525: Catheter Introducer, Galt Medical Corp. (2005) Summary page 4.
- K152528: Attachable Cath Lab Hemostasis Valve, Galt Medical Corp. (2015) Summary page 5.

## Recalls of this device
- 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 Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

Source page: https://510kreport.com/device/K173287
Methodology: https://510kreport.com/methodology