Home / 510(k) Clearances / K950069

510(k) K950069

DASHER-14 by Target Therapeutics — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1995
Date Received
January 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
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)

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  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)