BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT— 510(k) K133948

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K133948 for BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT, Substantially Equivalent on 2014-02-21. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-23
Decision date: 2014-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

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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.