# K222690: SmartGUIDE deflectable hydrophilic guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Artiria Medical SA
- Decided: Apr 24, 2023 after 230 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K002212 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190843: Synchro2 Support Guidewire, Stryker (2019) Summary page 4.
- K053268: PVS 2000 SYNCHRO2 Guidewire, Boston Scientific - Precision Vascular (2006) Summary page 4.

## Indications for use
SmartGUIDE guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K222690
Methodology: https://510kreport.com/methodology