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510(k) K964488

DETACHABLE SILICONE BALLOON (DSB) by Target Therapeutics — Product Code MZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
November 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Detachable, For Neurovascular Occlusion
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

Other clearances by Target Therapeutics

  • 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)
  • K960806 — TURBO TRACKER (May 2, 1996)

Other clearances for product code MZQ

  • K965071 — DETACHABLE SLICONE BALLOON (DSB) (April 21, 1998)