# K240746: Neurovascular Access System Family

- Pathway: 510(k) (Traditional)
- Applicant: Q'Apel Medical, Inc.
- Decided: Nov 20, 2024 after 246 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: 9 generations back to K010954 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212838: Benchmark Intracranial Access System, Penumbra, Inc. (2022) Summary page 5.
- K211893: SelectFlex Neurovascular Access System Family, Q'Apel Medical, Inc. (2021) Summary page 5.

## Indications for use
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.

Source page: https://510kreport.com/device/K240746
Methodology: https://510kreport.com/methodology