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510(k) K242608

Embozene Color-Advanced Microspheres by Varian Medical Systems, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
September 3, 2024
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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  • K250099 — Mobius3D (4.1) (May 16, 2025)
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  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K242957 — Identify (4.0) (February 7, 2025)
  • K241764 — Mould Probe MR Safe (January 10, 2025)

Other clearances for product code KRD

  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
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  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 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)
  • K240873 — TEMBO Embolic System (December 16, 2024)