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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K250032
Device Name Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
Applicant
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Rachel LaPoint
Correspondent
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Rachel LaPoint
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/07/2025
Decision Date 07/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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