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510(k) K140356

SUMMED HIGH PRESSURE LINE by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K120119 — SUNMED GUIDE WIRE (May 11, 2012)

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