# K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Perfuze, Ltd.
- Decided: Oct 18, 2023 after 61 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: 9 generations back to K003410 (2001). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173200: SOFIA Plus Aspiration Catheter, MicroVention, Inc. (2018) Summary page 4.

## Most influential descendants
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2024), 3 descendants of its own
- K250012: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2025), 1 descendant of its own
- K253901: Millipede88 Access Catheter (2026), 0 descendants of its own
- K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (2025), 0 descendants of its own

## Indications for use
Millipede 070 Aspiration Catheter The Millipede 070 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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Perfuze Aspiration Tube Set The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

Source page: https://510kreport.com/device/K232524
Methodology: https://510kreport.com/methodology