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510(k) K254221

Optima Coil System (OptiOne Coil System) by Balt USA, LLC — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2026
Date Received
December 29, 2025
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 Balt USA, LLC

  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (June 3, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K242376 — Next Generation Access Platform (December 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K234074 — Next Generation Access Catheter (July 2, 2024)
  • K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (July 2, 2024)
  • K230609 — NG Delivery Catheter (September 13, 2023)
  • K223386 — Optima Coil System (December 6, 2022)

Other clearances for product code HCG

  • K252694 — Target Detachable Coil (December 11, 2025)
  • 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)
  • K230284 — Penumbra LP Coil System (October 25, 2023)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)