NIAGARA SLIM-CATH— 510(k) K010778

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K010778 for NIAGARA SLIM-CATH, Substantially Equivalent on 2001-04-13. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2001-03-15
Decision date: 2001-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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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.