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510(k) K965071

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

K965071 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "DETACHABLE SLICONE BALLOON (DSB)". The FDA issued a decision of Substantially Equivalent on April 21, 1998. The device falls under product code MZQ (Balloon, Detachable, For Neurovascular Occlusion), a Class II device regulated under 21 CFR 882.5950. Target Therapeutics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
December 19, 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

  • K964488 — DETACHABLE SILICONE 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

  • K964488 — DETACHABLE SILICONE BALLOON (DSB) (April 21, 1998)

FDA data resources