# K262399: Millipede System

- Pathway: 510(k) (Special)
- Applicant: Perfuze, Ltd.
- Decided: Aug 12, 2026 after 29 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: 15 generations back to K003410 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253590: Millipede System, Perfuze, Ltd. (2026) Summary page 5.

## Indications for use
As part of the Millipede System, the Millipede88 Aspiration Catheter with the Perfuze Aspiration Tube Set and a compatible aspiration pump, 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. As part of the Millipede System, the Millipede70 Aspiration Catheter with the Perfuze Aspiration Tube Set and a compatible aspiration pump, 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. As part of the Millipede System, the Perfuze Aspiration Tube Set is indicated to connect the Millipede88 or Millipede70 Aspiration Catheter to a compatible aspiration pump.

Source page: https://510kreport.com/device/K262399
Methodology: https://510kreport.com/methodology