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510(k) K991549

EMBOSPHERE MICROSPHERES by Biosphere Medical — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2000
Date Received
May 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

Other clearances by Biosphere Medical

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  • K183578 — Torpedo Gelatin Foam (June 18, 2019)
  • K181021 — EmboCube Embolization Gelatin (September 27, 2018)
  • 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)

Other clearances for product code HCG

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  • K242154 — Numen™ Coil Embolization System; NumenFR™ Detachment System (September 30, 2024)
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  • K242243 — Target Detachable Coils (August 29, 2024)
  • K232955 — Numen Coil Embolization System; NumenFR Detachment System (January 10, 2024)
  • K233420 — Axium Detachable Coil; Axium Prime Detachable Coil (November 7, 2023)
  • K230284 — Penumbra LP Coil System (October 25, 2023)