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FDA 510(k)

CardioGard Emboli Protection Cannula

K-Number: K182302 · 2019-05-17

ApplicantCardiogard Medical, Ltd.
Decision Date2019-05-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioGard Emboli Protection Cannula is a medical device manufactured by Cardiogard Medical, Ltd.. It received FDA 510(k) clearance on 2019-05-17 under approval number K182302. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioGard Emboli Protection Cannula?

CardioGard Emboli Protection Cannula is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Cardiogard Medical, Ltd.. The 510(k) number is K182302.

When was CardioGard Emboli Protection Cannula approved by the FDA?

CardioGard Emboli Protection Cannula received FDA 510(k) clearance on 2019-05-17, under approval number K182302.

What company makes CardioGard Emboli Protection Cannula?

CardioGard Emboli Protection Cannula is manufactured by Cardiogard Medical, Ltd..

What is the FDA product code for CardioGard Emboli Protection Cannula?

The FDA product code for CardioGard Emboli Protection Cannula is DWF.

Related Clinical Trials

NCT06027788 CTSN Embolic Protection Trial RECRUITING NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

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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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