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510(k) K193653

Hydrophilic Coating Guide Wire by Suzhou Hengrui Disheng Medical Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
December 30, 2019
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 Suzhou Hengrui Disheng Medical Co., Ltd.

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  • K171665 — Microcatheter and guide-wire system (January 11, 2018)

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