PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER— 510(k) K033080

Substantially Equivalent

Portex, Inc.

FDA 510(k) clearance K033080 for PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER, Substantially Equivalent on 2004-03-10. Applicant: Portex, Inc..

Clearance details

Applicant: Portex, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2003-09-29
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.