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FDA 510(k)

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

K-Number: K261089 · 2026-09-14

ApplicantMaduro Medical, Inc.
Decision Date2026-09-14
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Maduro Medical, Inc.. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K261089. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit?

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Maduro Medical, Inc.. The 510(k) number is K261089.

When did Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit receive FDA 510(k) clearance?

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit received FDA 510(k) clearance on 2026-09-14, under 510(k) number K261089.

Who is the listed applicant for Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit?

The FDA 510(k) record lists Maduro Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit?

The FDA product code for Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit is NRY.

Other records listing Maduro Medical, Inc. as applicant

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K253975Radical 6F Access CatheterK243577Radical the Dude 8F Guide CatheterK231393Radical the Dude 7F Guide Catheter

Related Devices (Code: NRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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