# K200417: RIST Radial Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rist Neurovascular, Inc.
- Decided: May 2, 2020 after 72 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: 6 generations back to K010954 (2001). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142321: Benchmark Intracranial Access System, Penumbra, Inc. (2015) Summary page 4.

## Most influential descendants
- K201682: RIST Radial Access Catheter (2020), 2 descendants of its own
- K241388: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (2025), 1 descendant of its own
- K254178: SAYA 86 Radial Access Guide Catheter (2026), 0 descendants of its own

## Indications for use
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K200417
Methodology: https://510kreport.com/methodology