CONTINUOUS EPIDURAL ANESTHESIA TRAY— 510(k) K781052

Substantially Equivalent

Portex, Inc.

FDA 510(k) clearance K781052 for CONTINUOUS EPIDURAL ANESTHESIA TRAY, Substantially Equivalent on 1978-08-02. Applicant: Portex, Inc..

Clearance details

Applicant: Portex, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1978-06-22
Decision date: 1978-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.