# K202522: Synchro SELECT Guidewire

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Sep 25, 2020 after 24 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002212 (2000). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053268: PVS 2000 SYNCHRO2 Guidewire, Boston Scientific - Precision Vascular (2006) Summary page 5.

## Most influential descendants
- K243756: 0.014” Willow Guidewire (2025), 4 descendants of its own
- K253168: 0.014” Willow Guidewire (2025), 3 descendants of its own
- K260130: Willow 18 Guidewire (2026), 1 descendant of its own
- K262424: Willow 12 Guidewire (2026), 0 descendants of its own
- K260537: Willow 24 Guidewire (2026), 0 descendants of its own

## Recalls of this device
- Apr 18, 2024 · Class II · Z-1940-2024: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optiona

## Indications for use
The Synchro SELECT Guidewire series 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. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K202522
Methodology: https://510kreport.com/methodology