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510(k) K181021

EmboCube Embolization Gelatin by Biosphere Medical, S.A. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2018
Date Received
April 17, 2018
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

Other clearances by Biosphere Medical, S.A.

  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K192480 — Torpedo Gelatin Foam (November 21, 2019)
  • K183120 — EmboCube Embolization Gelatin (August 6, 2019)
  • K183578 — Torpedo Gelatin Foam (June 18, 2019)
  • K181300 — Embosphere Microspheres (July 16, 2018)
  • K172372 — QuadraSphere Microspheres (September 6, 2017)
  • DEN160040 — Embosphere Microspheres (June 21, 2017)
  • K153102 — QuadraSphere Microspheres (November 23, 2015)
  • K151187 — QuadraSphere Microspheres (July 27, 2015)
  • K113822 — QUADRASPHERE 30 TO 60 (March 8, 2012)

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)
  • 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)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)