Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fogarty Venous Thrombectomy Catheters

K-Number: K233819 · 2024-05-22

ApplicantEdwards Lifesciences, LLC
Decision Date2024-05-22
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Venous Thrombectomy Catheters is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-05-22 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K233819.

When was Fogarty Venous Thrombectomy Catheters approved by the FDA?

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

What company makes Fogarty Venous Thrombectomy Catheters?

Fogarty Venous Thrombectomy Catheters is manufactured by Edwards Lifesciences, LLC.

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

NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

View all 64 devices →

Related Devices (Code: DXE)

K163031Bunegin-Albin Air Aspiration SetCook Incorporated K163353Needle's Eye Snare Retrieval Set - 54cmCook Incorporated K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation K213771Merlin Aspiration SystemMivi Neurovascular, Inc. K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC

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.

↑