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. The code covers catheters that provide vascular access to the neurovasculature for interventional or diagnostic procedures.
Class II, 21 CFR 870.1250, filed as a Special 510(k). The record lists Cardiovascular as the advisory panel and Neurology as the review panel.
Maduro Medical filed from Los Gatos, California. Review took 119 days (December 11, 2025 to April 9, 2026).
Clearance details
- Applicant
- Maduro Medical, Inc.
- Product code
- Product 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.