Cleared Traditional

Concerto Versa? Detachable Coil

K253511 · Medtronic, Inc. · Cardiovascular
Jan 2026
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K253511 is an FDA 510(k) clearance for the Concerto Versa? Detachable Coil, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Medtronic, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 14, 2026, 70 days after receiving the submission on November 5, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K253511 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2025
Decision Date January 14, 2026
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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