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FDA 510(k)

Radical 6F Access Catheter

K-Number: K253975 · 2026-04-09

ApplicantMaduro Medical, Inc.
Decision Date2026-04-09
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radical 6F Access Catheter is a medical device manufactured by Maduro Medical, Inc.. It received FDA 510(k) clearance on 2026-04-09 under approval number K253975. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radical 6F Access Catheter?

Radical 6F Access Catheter is a medical device that received FDA 510(k) clearance on 2026-04-09. It is manufactured by Maduro Medical, Inc.. The 510(k) number is K253975.

When was Radical 6F Access Catheter approved by the FDA?

Radical 6F Access Catheter received FDA 510(k) clearance on 2026-04-09, under approval number K253975.

What company makes Radical 6F Access Catheter?

Radical 6F Access Catheter is manufactured by Maduro Medical, Inc..

What is the FDA product code for Radical 6F Access Catheter?

The FDA product code for Radical 6F Access Catheter is QJP.

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Other Devices by Maduro Medical, Inc.

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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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