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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiogard Medical, Ltd.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) 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. The listed applicant is Cardiogard Medical, Ltd.. The 510(k) number is K182302.

When did CardioGard Emboli Protection Cannula receive FDA 510(k) clearance?

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

Who is the listed applicant for CardioGard Emboli Protection Cannula?

The FDA 510(k) record lists Cardiogard Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06027788CTSN Embolic Protection TrialRECRUITING

Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.

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