Radical the Dude 8F Guide Catheter— 510(k) K243577
Substantially EquivalentMaduro Medical, Inc.
FDA 510(k) clearance K243577 for Radical the Dude 8F Guide Catheter, Substantially Equivalent on 2025-01-14. Applicant: Maduro Medical, Inc..
Clearance details
- Applicant
- Maduro Medical, Inc.
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Campbell, 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.