# K231393: Radical the Dude 7F Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Maduro Medical, Inc.
- Decided: Nov 30, 2023 after 202 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). 10 ancestors in all.
2 later devices descend from it; 2 cite 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
- K253975: Radical 6F Access Catheter (2026), 0 descendants of its own
- K243577: Radical the Dude 8F Guide Catheter (2025), 0 descendants of its own

## Indications for use
The Radical the Dude 7F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K231393
Methodology: https://510kreport.com/methodology