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510(k) K962503

GUGLIELMI DETACHABLE COIL by Target Therapeutics — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1996
Date Received
June 27, 1996
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 Target Therapeutics

  • K964488 — DETACHABLE SILICONE BALLOON (DSB) (April 21, 1998)
  • K965071 — DETACHABLE SLICONE BALLOON (DSB) (April 21, 1998)
  • K964210 — RETRIEVER II (October 31, 1997)
  • K971395 — GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LI (July 14, 1997)
  • K965189 — SPINNAKER (March 24, 1997)
  • K964112 — BERENSTEIN COIL (February 26, 1997)
  • K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 45021 (December 17, 1996)
  • K961923 — BERENSTEIN COIL (August 15, 1996)
  • K960705 — GUGLIELMI DETACHABLE COIL (May 21, 1996)
  • K960806 — TURBO TRACKER (May 2, 1996)

Other clearances for product code HCG

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • 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)