# K261089: Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maduro Medical, Inc.
- Decided: Sep 14, 2026 after 166 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: 13 generations back to K003410 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191768: AXS Vecta Aspiration System, Stryker Neurovascular (2019) Summary page 5.

## Indications for use
Radical 064 Reperfusion Catheter The Radical 064 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral — M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Radical 076 Reperfusion Catheter The Radical 076 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Radical Aspiration Tubing Kit The Radical Aspiration Tubing Kit is intended to connect the Radical Reperfusion Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Source page: https://510kreport.com/device/K261089
Methodology: https://510kreport.com/methodology