# K190212: AXS Vecta Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Apr 24, 2019 after 79 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003410 (2001). 14 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181354: 074 Zenith Flex System, Inneuroco, Inc. (2018) Summary page 5.

## Most influential descendants
- K191768: AXS Vecta Aspiration System (2019), 4 descendants of its own
- K243601: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (2025), 2 descendants of its own
- K253590: Millipede System (2026), 1 descendant of its own
- K261089: Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (2026), 0 descendants of its own
- K262399: Millipede System (2026), 0 descendants of its own

## Indications for use
The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K190212
Methodology: https://510kreport.com/methodology