# K182660: GaltTWS

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: May 30, 2019 after 247 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000313 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992664: TFX Medical Stylet Catheter, Tfx Medical Group (2000) Summary page 4.
- K982559: Guidewire, Galt Medical Corp. (1999) Summary page 4.
- K152528: Attachable Cath Lab Hemostasis Valve, Galt Medical Corp. (2015) Summary page 5.

## Most influential descendants
- K220280: Arrow Stiffening Stylet (2022), 0 descendants of its own

## Indications for use
The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

Source page: https://510kreport.com/device/K182660
Methodology: https://510kreport.com/methodology