# K240529: 8F Modified Sheath System

- Pathway: 510(k) (Special)
- Applicant: Route 92 Medical, Inc.
- Decided: Oct 2, 2024 after 222 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: 8 generations back to K010954 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191717: Route 92 Medical Sheath System, Route 92 Medical, Inc. (2020) Summary page 5.

## Indications for use
The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K240529
Methodology: https://510kreport.com/methodology