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FDA 510(k)

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

K-Number: K260195 · 2026-04-23

ApplicantMedtronic, Inc.
Decision Date2026-04-23
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K260195. 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 Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Medtronic, Inc.. The 510(k) number is K260195.

When was Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae approved by the FDA?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae received FDA 510(k) clearance on 2026-04-23, under approval number K260195.

What company makes Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is manufactured by Medtronic, Inc..

What is the FDA product code for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

The FDA product code for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is DWF.

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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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