# K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

- Pathway: 510(k) (Special)
- Applicant: Perfuze, Ltd.
- Decided: Aug 29, 2025 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: 13 generations back to K010954 (2001). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250012: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, Perfuze, Ltd. (2025) Summary page 5.

## Indications for use
Millipede70 Aspiration Catheter 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. Perfuze Aspiration Tube Set The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.

Source page: https://510kreport.com/device/K252392
Methodology: https://510kreport.com/methodology