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..
Summary
The Radical 6F Access Catheter is a peripheral vascular access catheter — product code QJP covers interventional cardiology and peripheral catheter systems. The "6F" designation (6 French outer diameter) is a standard size for large-bore interventional access, used in carotid, peripheral, and structural-heart procedures.
Cardiovascular panel, Special 510(k) — Maduro Medical filed this as a modification to an existing cleared device rather than a new platform. Special pathway usually clears minor dimensional, material, or labeling changes.
Maduro Medical, Inc. files from Los Gatos, CA. Four-month review clock, longer than typical for Special 510(k), which can happen when FDA asks additional questions despite the Special designation.
Clearance details
- Applicant
- Maduro Medical, Inc.
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Gatos, CA, US
Adverse 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.