# K252122: DCwire Micro-guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Achieva Medical Suzhou Co., Ltd.
- Decided: Mar 16, 2026 after 252 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)
- K202522: Synchro SELECT Guidewire, Stryker Neurovascular (2020) Summary page 5.
- K032146: PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires, Precision Vascular Systems, Inc. (2003) Summary page 5.

## Indications for use
The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K252122
Methodology: https://510kreport.com/methodology