Zenysis Short-Term Dialysis Catheter— 510(k) K153190

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K153190 for Zenysis Short-Term Dialysis Catheter, Substantially Equivalent on 2016-01-05. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-03
Decision date: 2016-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.