CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI— 510(k) K924530

Substantially Equivalent

Cabot Medical Corp.

FDA 510(k) clearance K924530 for CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI, Substantially Equivalent on 1993-02-05. Applicant: Cabot Medical Corp..

Clearance details

Applicant: Cabot Medical Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1992-09-08
Decision date: 1993-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.