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510(k) K250209

Polyvinyl Alcohol Embolic Microspheres by Canyon Medical, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2025
Date Received
January 24, 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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  • K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-A (April 3, 2023)

Other clearances for product code KRD

  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253677 — Tembo Embolic System (December 15, 2025)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K250276 — Nitinol Enhanced Device (NED) (May 15, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)
  • K240873 — TEMBO Embolic System (December 16, 2024)