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510(k) K955293

FIBERED PLATINUM COIL, .035 TYPE by Target Therapeutics — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1996
Date Received
November 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
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)
  • K962503 — GUGLIELMI DETACHABLE COIL (September 20, 1996)
  • K961923 — BERENSTEIN COIL (August 15, 1996)
  • K960705 — GUGLIELMI DETACHABLE COIL (May 21, 1996)

Other clearances for product code KRD

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  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K250276 — Nitinol Enhanced Device (NED) (May 15, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)