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510(k) K120119

SUNMED GUIDE WIRE by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2012
Date Received
January 17, 2012
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)
  • K153685 — Sunmed Haemostatic Valves (October 13, 2016)
  • K140356 — SUMMED HIGH PRESSURE LINE (March 20, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)

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