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510(k) K250032

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit by Bard Peripheral Vascular, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2025
Date Received
January 7, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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