Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit— 510(k) K261089
Substantially EquivalentMaduro Medical, Inc.
FDA 510(k) clearance K261089 for Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit, Substantially Equivalent on 2026-09-14. Applicant: Maduro Medical, Inc.. Device class: 2.
Summary
Maduro Medical, Inc. submitted three items under product code NRY (Catheter, Thrombus Retriever): the Radical 064 Reperfusion Catheter, the Radical 076 Reperfusion Catheter, and the Radical Aspiration Tubing Kit. The record has no further detail on them.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel. The decision was Substantially Equivalent.
Maduro filed from Los Gatos, California. The decision came 166 calendar days after receipt (April 1 to September 14, 2026).
Clearance details
- Applicant
- Maduro Medical, Inc.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Gatos, CA, US
Recent devices under product code NRY
view allMore clearances from Maduro Medical, Inc.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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.