# K201682: RIST Radial Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rist Neurovascular, Inc.
- Decided: Sep 28, 2020 after 98 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). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150366: SOFIA 6F Catheter, MicroVention, Inc. (2015) Summary page 4.
- K200417: RIST Radial Access Catheter, Rist Neurovascular, Inc. (2020) Summary page 4.

## Most influential descendants
- 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. It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

Source page: https://510kreport.com/device/K201682
Methodology: https://510kreport.com/methodology