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510(k) K171665

Microcatheter and guide-wire system by Suzhou Hengrui Disheng Medical Co., Ltd. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2018
Date Received
June 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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