NIAGARA DUAL LUMEN CATHETER— 510(k) K965178

Substantially Equivalent

Vas-Cath, Inc.

FDA 510(k) clearance K965178 for NIAGARA DUAL LUMEN CATHETER, Substantially Equivalent on 1997-08-19. Applicant: Vas-Cath, Inc..

Clearance details

Applicant: Vas-Cath, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-24
Decision date: 1997-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L5a 3v3, CA

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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.