K011125

Substantially Equivalent

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI

Applicant: Hudson Respiratory Care, Inc.
Product code: CAT
Advisory panel: Anesthesiology
Date received: 2001-04-13
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.