# K172487: Coaxial Dilator Set (Micro-Introducer)

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Oct 16, 2017 after 60 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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: 1 generation back to K000737 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000737: Coaxial Dilator Set, Xentek Medical, Inc. (2000) Summary page 4.

## Most influential descendants
- K192195: Sterile Dilator (2019), 0 descendants of its own

## Recalls of this device
- May 2, 2018 · Class II · Z-2561-2018: 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-2564-2018: 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
These Coaxial Dilator Sets are intended to introduce up to a 0.038 in. guidewire or catheter into the vascular system following a small gauge needle stick

Source page: https://510kreport.com/device/K172487
Methodology: https://510kreport.com/methodology