Concerto Versa Detachable Coil— 510(k) K253511

Name: FDA 510(k) clearance K253511
Creator: U.S. Food and Drug Administration
Published: 2026-01-14

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K253511 for Concerto Versa Detachable Coil, Substantially Equivalent on 2026-01-14. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2025-11-05
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRD

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K252812 — UniPearls® Embolic Microspheres2026-07-31
K261488 — OBSIDIO Conformable Embolic2026-07-24
K261866 — Concerto Versa Detachable Coil2026-06-24
K260635 — HARBOR Occlusion Device2026-06-12
K260508 — LOBO Vascular Occlusion System2026-04-10

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K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.