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510(k) K253511

Concerto Versa™ Detachable Coil by Medtronic, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2026
Date Received
November 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

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Other clearances for product code KRD

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  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)
  • K240873 — TEMBO Embolic System (December 16, 2024)