Argyle Cardioplegia Cannula

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K874834 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What is the primary purpose of the Argyle Cardioplegia Cannula in surgical procedures?

  The Argyle Cardioplegia Cannula is specifically designed for cardiopulmonary bypass procedures to deliver cardioplegic solutions directly into the coronary arteries. This action induces temporary cardiac arrest during open-heart surgery, protecting the heart muscle (myocardium) from ischemia and damage during the procedure.

• Is the Argyle Cardioplegia Cannula intended for reuse, or is it meant for single-use only?

  The Argyle Cardioplegia Cannula is explicitly intended for single-use only in sterile surgical settings. It must be handled using aseptic techniques to maintain sterility, as reuse is not recommended or supported by its design or regulatory classification.

• How is the Argyle Cardioplegia Cannula supplied, and what precautions should be taken during handling?

  The device is supplied sterile and must be used in sterile surgical environments. Since it is single-use, it should be opened and handled with strict aseptic techniques to prevent contamination. Always follow manufacturer guidelines for unpacking and preparation to ensure sterility is maintained.

• What regulatory pathway was used for FDA clearance of the Argyle Cardioplegia Cannula, and what does this mean for its use?

  The Argyle Cardioplegia Cannula received FDA clearance through the Traditional 510(k) pathway (K874834) and is classified as a Class II medical device under regulation number 870.4210. This means it has been deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness for its intended use in cardiopulmonary bypass procedures.

• Are there different sizes or models of the Argyle Cardioplegia Cannula, and how would I determine the correct one for a procedure?

  While the provided data does not specify exact sizes or models in detail, the Argyle Cardioplegia Cannula is listed under multiple OpenFDA registration numbers, indicating it may come in various configurations to accommodate different patient anatomies or procedural needs. Consult the manufacturer’s catalog or surgical guidelines to select the appropriate size or model based on patient-specific factors like coronary artery anatomy and cannulation requirements.