Cleared Special

K260195 - Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

K260195 is an FDA 510(k) clearance for Elongated One-Piece Arterial (EOPA) 3D ..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 91-day FDA review.

K260195 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
91d
Days
Class 2
Risk

K260195 is an FDA 510(k) clearance for the Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260195

510(k) Number K260195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2026
Decision Date April 23, 2026
Days to Decision 91 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 404
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K260195.
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K253203 · Medtronic, Inc. · Feb 2026
K260195 · Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
Download PDF FDA Summary Medtronic, Inc.