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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / April 2026 / K260195

510(k) cleared

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

Medtronic, Inc. · Apr 23, 2026 · K260195

FDA cleared the Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae from Medtronic, Inc. on Apr 23, 2026 under K260195, a special 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 22, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface).

Questions & Answers

What did FDA clear under K260195?

K260195 is the FDA 510(k) for Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae, submitted by Medtronic, Inc.. FDA's decision date was Apr 23, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae?

Medtronic, Inc., based in Mounds View, MN, is the applicant of record for K260195.

How long did the K260195 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Apr 23, 2026, 91 days later.

← All decisions in April 2026