# K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

- Pathway: 510(k) (Special)
- Applicant: Perfuze, Ltd.
- Decided: Sep 20, 2024 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: 11 generations back to K010954 (2001). 29 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233648: Millipede 088 Access Catheter, Perfuze, Ltd. (2023) Summary page 5.
- K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, Perfuze, Ltd. (2023) Summary page 5.

## Most influential descendants
- 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 088 Access Catheter The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. 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/K242504
Methodology: https://510kreport.com/methodology