# K192195: Sterile Dilator

- Pathway: 510(k) (Special)
- Applicant: Galt Medical Corp.
- Decided: Sep 26, 2019 after 44 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000737 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172487: Coaxial Dilator Set (Micro-Introducer), Galt Medical Corp. (2017) Summary page 4.

## Indications for use
These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature.

Source page: https://510kreport.com/device/K192195
Methodology: https://510kreport.com/methodology