CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP— 510(k) K941743

Substantially Equivalent

Cabot Medical Corp.

FDA 510(k) clearance K941743 for CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP, Substantially Equivalent on 1995-04-19. Applicant: Cabot Medical Corp..

Clearance details

Applicant: Cabot Medical Corp.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1994-04-07
Decision date: 1995-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.