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FDA 510(k)

LungFlow Basket Catheter

K-Number: K254040 · 2026-03-12

ApplicantFree Flow Medical, Inc.
Decision Date2026-03-12
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LungFlow Basket Catheter is a medical device manufactured by Free Flow Medical, Inc.. It received FDA 510(k) clearance on 2026-03-12 under approval number K254040. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungFlow Basket Catheter?

LungFlow Basket Catheter is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Free Flow Medical, Inc.. The 510(k) number is K254040.

When was LungFlow Basket Catheter approved by the FDA?

LungFlow Basket Catheter received FDA 510(k) clearance on 2026-03-12, under approval number K254040.

What company makes LungFlow Basket Catheter?

LungFlow Basket Catheter is manufactured by Free Flow Medical, Inc..

What is the FDA product code for LungFlow Basket Catheter?

The FDA product code for LungFlow Basket Catheter is KTI.

Related Clinical Trials

NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT06412354 EasyCrossTM Device-Self-centering Catheter COMPLETED

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Official Source

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

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