510(k) clearances

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

Maduro Medical, Inc. · Cardiovascular

K261089Substantially EquivalentTraditionalNRY
Open FDA's page for this record
Third party flag
N
City
Los Gatos
Advisory committee description
Cardiovascular
Address 1
983 University Ave.
Address 2
Bldg. A
Statement or summary
Summary
Product code
NRY
Zip code
95032
Applicant
Maduro Medical, Inc.
Decision date
2026-09-14
Decision code
SESE
Country code
US
Device name
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
Advisory committee
CV
Contact
Janice Kemp
K number
K261089
State
CA
Date received
2026-04-01
Review advisory committee
NE
Postal code
95032
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Thrombus Retriever
Medical specialty description
Cardiovascular
Regulation number
870.1250
Device class
2
Registration number
3010034260, 3019807891, 3021009035, 3009380063, 3016522967, 3007628272, 3039020025, 2024311, 3015531723, 3015615738, 3002807314, 3015550451, 3014644549, 3009957947, 3021520400, 3003144120, 3008824097, 3006451981, 1220477, 2183828, 3014162263, 3007007790, 3008853977, 3008114965, 3011370111, 1721676, 3009337401, 3030088112, 3012931345, 2183744, 3008837339, 3012497308, 3008264254, 9616664, 3014590708, 3015453963, 1048735, 2011171, 3008881809, 3009546466 +20 more
FEI number
3010034260, 3019807891, 3021009035, 3009380063, 3016522967, 3007628272, 3039020025, 2024311, 3015531723, 3015615738, 3002807314, 3015550451, 3014644549, 3009957947, 3021520400, 3008824097, 3006451981, 1220477, 2183828, 3014162263, 3007007790, 3008853977, 3008114965, 3011370111, 1721676, 3009337401, 3030088112, 3012931345, 2183744, 3008837339, 3012497308, 3008264254, 3014590708, 3015453963, 1048735, 2011171, 3008881809, 3009546466, 3010079067, 3031288142 +20 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.