Data / Medical devices / United States / Maduro Medical, Inc.

Maduro Medical, Inc.: FDA-registered device maker in Los Gatos, CA, United States, 4 510(k) clearances

Name: Maduro Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Maduro Medical, Inc. is registered with the FDA (registration 3027319104) in Los Gatos, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 14, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3027319104
Address: 983 University Ave Bldg A, Los Gatos, CA, United States, 95032
Owner or operator: Maduro Medical, Inc. (10089513)
Roles: Complaint file establishment, Manufacturer
First device listed: December 13, 2023
Registered through: 2026
Brand names listed: Radical 064 Reperfusion Catheter, Radical 076 Reperfusion Catheter, Radical 6F Access Catheter, Radical the Dude 7F Guide Catheter, Radical the Dude 8F Guide Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2026	K261089	Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit	NRY	Substantially Equivalent	Maduro Medical, Inc.	accessdata.fda.gov
April 9, 2026	K253975	Radical 6F Access Catheter	QJP	Substantially Equivalent	Maduro Medical, Inc.	accessdata.fda.gov
January 14, 2025	K243577	Radical the Dude 8F Guide Catheter	QJP	Substantially Equivalent	Maduro Medical, Inc.	accessdata.fda.gov
November 30, 2023	K231393	Radical the Dude 7F Guide Catheter	QJP	Substantially Equivalent	Maduro Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.