FDA 510(k)

Clearview Intracoronary Shunts

K-Number: K253998 · 2026-01-20

Decision Date2026-01-20

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Clearview Intracoronary Shunts is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253998. 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 Clearview Intracoronary Shunts?

Clearview Intracoronary Shunts is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Medtronic, Inc.. The 510(k) number is K253998.

When did Clearview Intracoronary Shunts receive FDA 510(k) clearance?

Clearview Intracoronary Shunts received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253998.

Who is the listed applicant for Clearview Intracoronary Shunts?

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 Clearview Intracoronary Shunts?

The FDA product code for Clearview Intracoronary Shunts is DWF.

Related Clinical Trials

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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITING NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

Other records listing Medtronic, Inc. as applicant

PMA P960009Stimulator, electrical, implanted, for parkinsonian tremor PMA P860004Pump, infusion, implanted, programmable PMA P130021Aortic valve, prosthesis, percutaneously delivered PMA P240013Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P100047Ventricular (assist) bypass PMA P980035Pulse generator, permanent, implantable

View all 166 devices →

Related Devices (Code: DWF)

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253106AngioVac CannulaAngioDynamics, Inc.

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.