# K253901: Millipede88 Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Perfuze, Ltd.
- Decided: Jul 9, 2026 after 216 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 12 generations back to K010954 (2001). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, Perfuze, Ltd. (2024) Summary page 5.

## Indications for use
The Millipede88 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

Source page: https://510kreport.com/device/K253901
Methodology: https://510kreport.com/methodology