Cleared Special

K263596 - DLP™ Coronary Ostial Cannulae

K263596 is an FDA 510(k) clearance for DLP Coronary Ostial Cannulae, 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 29-day FDA review.

K263596 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263596 is an FDA 510(k) clearance for the DLP™ Coronary Ostial Cannulae. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Brooklyn Park, US). The FDA issued a Cleared decision on October 29, 2026 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K263596

510(k) Number K263596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2026
Decision Date October 29, 2026
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 403
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K263596.
AngioVac F1885
K263076 · AngioDynamics, Inc. · Oct 2026
Dual Stage Venous Cannulae
K263092 · Sorin Group Italia S.R.L. · Oct 2026
Tri Stage Venous Cannulae
K262052 · Sorin Group Italia S.R.L. · Sep 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · Medtronic, Inc. · Apr 2026
Venous Return Cannulae
K250937 · LivaNova USA, Inc. · Mar 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
K260043 · Smart Reactors · Feb 2026
K263596 · DLP™ Coronary Ostial Cannulae
Download PDF FDA Summary Medtronic, Inc.