510(k) K250032

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

K250032 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "Marquee™ Disposable Core Biopsy Instrument and Instrument Kit". The FDA issued a decision of Substantially Equivalent on July 10, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.