Home / 510(k) Clearances / K153685

510(k) K153685

Sunmed Haemostatic Valves by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2016
Date Received
December 22, 2015
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 Sunny Medical Device (Shenzhen) Co., Ltd.

  • K191827 — Sunmed Disposable Angio-Closure Pads (March 16, 2020)
  • K160190 — Sunmed Control Syringes (November 10, 2016)
  • K140356 — SUMMED HIGH PRESSURE LINE (March 20, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K120119 — SUNMED GUIDE WIRE (May 11, 2012)

Other clearances for product code DQX

  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • 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)