# K241388: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jan 2, 2025 after 232 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: 9 generations back to K010954 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 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 5.
- K211990: Rist 071 Radial Access Guide Catheter, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2021) Summary page 5.
- K201682: RIST Radial Access Catheter, Rist Neurovascular, Inc. (2020) Summary page 5.

## Most influential descendants
- K254178: SAYA 86 Radial Access Guide Catheter (2026), 0 descendants of its own

## Indications for use
The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The Rist™ Radial Access Selective 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/K241388
Methodology: https://510kreport.com/methodology