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FDA 510(k)

Fogarty Thru-Lumen Embolectomy Catheter

K-Number: K240078 · 2024-08-28

ApplicantEdwards Lifesciences, LLC
Decision Date2024-08-28
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Thru-Lumen Embolectomy Catheter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-08-28 under approval number K240078. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fogarty Thru-Lumen Embolectomy Catheter?

Fogarty Thru-Lumen Embolectomy Catheter is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K240078.

When was Fogarty Thru-Lumen Embolectomy Catheter approved by the FDA?

Fogarty Thru-Lumen Embolectomy Catheter received FDA 510(k) clearance on 2024-08-28, under approval number K240078.

What company makes Fogarty Thru-Lumen Embolectomy Catheter?

Fogarty Thru-Lumen Embolectomy Catheter is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Fogarty Thru-Lumen Embolectomy Catheter?

The FDA product code for Fogarty Thru-Lumen Embolectomy Catheter is DXE.

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Related Devices (Code: DXE)

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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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