510(k) clearance
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- 510(k) number
- K261089
- Applicant
- Maduro Medical, Inc.
- Decision date
- Sep 14, 2026
- Date received
- Apr 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NRY
- Device type
- Catheter, Thrombus Retriever
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Los Gatos, CA, US