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510(k) K113822

QUADRASPHERE 30 TO 60 by Biosphere Medical, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2012
Date Received
December 27, 2011
Clearance Type
Special
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

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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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  • K230284 — Penumbra LP Coil System (October 25, 2023)