# K253975: Radical 6F Access Catheter

- Pathway: 510(k) (Special)
- Applicant: Maduro Medical, Inc.
- Decided: Apr 9, 2026 after 119 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231393: Radical the Dude 7F Guide Catheter, Maduro Medical, Inc. (2023) Summary page 5.

## Indications for use
The Radical 6F Access Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K253975
Methodology: https://510kreport.com/methodology