Marquee Disposable Core Biopsy Instrument and Instrument Kit— 510(k) K250032

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K250032 for Marquee Disposable Core Biopsy Instrument and Instrument Kit, Substantially Equivalent on 2025-07-10. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-07
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.