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510(k) K244061

X-Wire Guidewire by Imperative Care, Inc. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2025
Date Received
December 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type

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