FDA 510(k)

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

K-Number: K193379 · 2020-06-12

Decision Date2020-06-12

Product CodeDXE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe 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 2020-06-12 under 510(k) number K193379. 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 Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe?

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe is a medical device that received FDA 510(k) clearance on 2020-06-12. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193379.

When did Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe receive FDA 510(k) clearance?

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe received FDA 510(k) clearance on 2020-06-12, under 510(k) number K193379.

Who is the listed applicant for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe?

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 Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe?

The FDA product code for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe is DXE.

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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 K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences K213771Merlin Aspiration SystemMivi Neurovascular, Inc.

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.