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510(k) K221575

Pre-Formed Blue by Lake Region Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
June 1, 2022
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

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  • K133155 — HYDROPHILIC COATED GUIDEWIRE (April 7, 2014)
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