EOPA Elongated One-Piece Arterial Cannula With Guidewire

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

510(k) Number

K000274 ↗

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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• What is the primary use of the EOPA Elongated One-Piece Arterial Cannula With Guidewire in a clinical setting?

  The EOPA Elongated One-Piece Arterial Cannula With Guidewire is specifically designed for use during cardiopulmonary bypass procedures. It provides arterial access to facilitate blood flow through the cannula during extracorporeal circulation, ensuring effective perfusion support for patients undergoing cardiac surgery.

• Is this cannula intended for single-use or can it be reused?

  The EOPA Elongated One-Piece Arterial Cannula With Guidewire is explicitly supplied as a single-use device. This ensures sterility and safety for controlled clinical environments like operating rooms, where it is intended to be used only once per patient.

• What French sizes are available for the EOPA Elongated One-Piece Arterial Cannula With Guidewire?

  The cannula is available in specific French sizes, including 20 Fr and 22 Fr, though the exact range of sizes may vary based on the model or batch. These sizes are designed to accommodate different patient anatomies during cardiopulmonary bypass procedures.

• How is the sterility of this device maintained, and what storage conditions should be followed?

  The EOPA Elongated One-Piece Arterial Cannula With Guidewire is sterile as supplied, ensuring it is ready for immediate use in sterile clinical environments like operating rooms. While the device data does not specify exact storage conditions, sterile medical devices like this typically require protection from contamination—such as keeping packaging intact, avoiding exposure to moisture or extreme temperatures, and storing in a clean, dry area until use.

• What regulatory pathway was followed for the clearance of this device, and which advisory committee was involved?

  The EOPA Elongated One-Piece Arterial Cannula With Guidewire received a Special 510(k) clearance under the FDA’s Cardiovascular (CV) advisory committee. This clearance was granted in 2000, confirming its substantial equivalence to a predicate device, and it is classified as a Class II medical device under FDA regulations.