K231393
- 510(k) number
- K231393
- Device name
- Radical the Dude 7F Guide Catheter
- Applicant
- Maduro Medical, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2023-11-30
- Date received
- 2023-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231393.pdf
Official FDA record: K231393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.