FDA 510(k)

Fogarty Venous Thrombectomy Catheters

K-Number: K233819 · 2024-05-22

Decision Date2024-05-22

Product CodeDXE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fogarty Venous Thrombectomy Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K233819. 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 Venous Thrombectomy Catheters?

Fogarty Venous Thrombectomy Catheters is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K233819.

When did Fogarty Venous Thrombectomy Catheters receive FDA 510(k) clearance?

Fogarty Venous Thrombectomy Catheters received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233819.

Who is the listed applicant for Fogarty Venous Thrombectomy Catheters?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fogarty Venous Thrombectomy Catheters?

The FDA product code for Fogarty Venous Thrombectomy Catheters is DXE.

Related Clinical Trials

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Other records listing Edwards Lifesciences, LLC as applicant

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Related Devices (Code: DXE)

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences K213771Merlin Aspiration SystemMivi Neurovascular, Inc.K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation

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.