# K191551: RIST Cath Radial Access Long Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Rist Neurovascular, Inc.
- Decided: Dec 23, 2019 after 194 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: 7 generations back to K010954 (2001). 9 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM, Tni Manufacturing, Inc. (2016) Summary page 4.

## Most influential descendants
- K231393: Radical the Dude 7F Guide Catheter (2023), 2 descendants of its own
- K211990: Rist 071 Radial Access Guide Catheter (2021), 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
- K253975: Radical 6F Access Catheter (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K191551
Methodology: https://510kreport.com/methodology