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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K260195.

When did Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae receive FDA 510(k) clearance?

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

Who is the listed applicant for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

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

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.

Related Clinical Trials

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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.

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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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