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510(k) K123338

BARRICADE EMBOLIZATION COIL SYSTEM by Blockade Medical — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
October 31, 2012
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 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)
  • K131475 — BARRICADE EMBOLIZATION COIL SYSTEM (July 25, 2013)

Other clearances for product code HCG

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  • K251832 — InZone IST Detachment System; IZDS Connecting Cable (October 17, 2025)
  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K242154 — Numen™ Coil Embolization System; NumenFR™ Detachment System (September 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • 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)