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FDA 510(k)

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

K-Number: K193379 · 2020-06-12

ApplicantEdwards Lifesciences, LLC
Decision Date2020-06-12
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2020-06-12 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K193379.

When was Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe approved by the FDA?

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

What company makes Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe?

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe is manufactured by Edwards Lifesciences, LLC.

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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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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