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510(k) K131475

BARRICADE EMBOLIZATION COIL SYSTEM by Blockade Medical — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2013
Date Received
May 22, 2013
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

Other clearances by Blockade Medical

  • K151760 — Barricade Embolization Coil System (July 27, 2015)
  • K142513 — Barricade Embolization Coil System (November 13, 2014)
  • K140104 — BARRICADE EMBOLIZATION COIL SYSTEM (February 13, 2014)
  • K132482 — BARRICADE EMBOLIZATION COIL SYSTEM (October 10, 2013)
  • K123338 — BARRICADE EMBOLIZATION COIL SYSTEM (March 28, 2013)

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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)