# K220280: Arrow Stiffening Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
- Decided: Aug 30, 2022 after 210 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: 5 generations back to K000313 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182660: GaltTWS, Galt Medical Corp. (2019) Summary page 4.

## Indications for use
The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.

Source page: https://510kreport.com/device/K220280
Methodology: https://510kreport.com/methodology