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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 a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-14 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K253511.

When was Concerto Versa™ Detachable Coil approved by the FDA?

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

What company makes Concerto Versa™ Detachable Coil?

Concerto Versa™ Detachable Coil is manufactured by Medtronic, Inc..

What is the FDA product code for Concerto Versa™ Detachable Coil?

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.