# K190843: Synchro2 Support Guidewire

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: May 1, 2019 after 30 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 8 (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.
1 later device descends from it; 1 cites it directly.
0 of 8 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 4.

## Most influential descendants
- K222690: SmartGUIDE deflectable hydrophilic guidewire (2023), 0 descendants of its own

## Recalls of this device
- Jun 8, 2018 · Class II · Z-0230-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0225-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0231-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0232-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0226-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0227-2020: 
- Jun 8, 2018 · Class II · Z-0228-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc
- Jun 8, 2018 · Class II · Z-0229-2020: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correc

## Indications for use
The Synchro2 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/K190843
Methodology: https://510kreport.com/methodology