# K203043: Route 92 Medical 070 Access System

- Pathway: 510(k) (Special)
- Applicant: Route 92 Medical, Inc.
- Decided: Nov 11, 2020 after 36 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010954 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201518: Route 92 Medical 088 Access System, Route 92 Medical (2020) Summary page 4.

## Recalls of this device
- Mar 8, 2024 · Class I · Z-1612-2024: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

## Indications for use
The Route 92 Medical 070 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Source page: https://510kreport.com/device/K203043
Methodology: https://510kreport.com/methodology