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510(k) K221351

Mechanical Guidewire by Baylis Medical Company, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2022
Date Received
May 10, 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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