Radical 6F Access Catheter— 510(k) K253975
Substantially EquivalentMaduro Medical, Inc.
FDA 510(k) clearance K253975 for Radical 6F Access Catheter, Substantially Equivalent on 2026-04-09. Applicant: Maduro Medical, Inc.. Device class: 2.
Summary
The Radical 6F Access Catheter is a 6 French catheter filed under QJP, percutaneous catheters for the neurovasculature. These give access to the vessels of the brain for neurointerventional procedures.
Class II, 21 CFR 870.1250, Cardiovascular panel. It's a Special 510(k), so Maduro Medical was modifying a catheter it already had cleared.
The company filed from Los Gatos, California. Review took 119 days (December 11, 2025 to April 9, 2026). That's long for a Special, a pathway meant to handle contained changes quickly.
Clearance details
- Applicant
- Maduro Medical, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Gatos, CA, US
Recent devices under product code QJP
view allMore clearances from Maduro Medical, Inc.
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.