# K240871: Synxess Neurovascular Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Enlight Medical Technologies (Shenzhen) Co., Ltd.
- Decided: Nov 18, 2024 after 234 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: 6 generations back to K890505 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110584: Asahi Chikai Neurovascular Guide Wire, Asahi Intecc Co., Ltd. (2011) Summary page 5.
- K112979: Asahi Chikai 10 Neurovascular Guide Wire, Asahi Intecc Co., Ltd. (2011) Summary page 5.

## Indications for use
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.

Source page: https://510kreport.com/device/K240871
Methodology: https://510kreport.com/methodology