FDA 510(k)

Concerto Versa™ Detachable Coil

K-Number: K253511 · 2026-01-14

Decision Date2026-01-14

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Concerto Versa™ Detachable Coil is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K253511. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concerto Versa™ Detachable Coil?

Concerto Versa™ Detachable Coil is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Medtronic, Inc.. The 510(k) number is K253511.

When did Concerto Versa™ Detachable Coil receive FDA 510(k) clearance?

Concerto Versa™ Detachable Coil received FDA 510(k) clearance on 2026-01-14, under 510(k) number K253511.

Who is the listed applicant for Concerto Versa™ Detachable Coil?

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 Concerto Versa™ Detachable Coil?

The FDA product code for Concerto Versa™ Detachable Coil is KRD.

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 NCT07639853Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable CoilsENROLLING_BY_INVITATION

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Related Devices (Code: KRD)

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253677Tembo Embolic SystemInstylla, 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.