# K211990: Rist 071 Radial Access Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jul 27, 2021 after 29 days
- Product code: DQY (Catheter, Percutaneous)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191551: RIST Cath Radial Access Long Sheath, Rist Neurovascular, Inc. (2019) 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™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K211990
Methodology: https://510kreport.com/methodology