OXY-CATH— 510(k) K881428

Substantially Equivalent

Pulmonary Medical Devices, Inc.

FDA 510(k) clearance K881428 for OXY-CATH, Substantially Equivalent on 1988-06-10. Applicant: Pulmonary Medical Devices, Inc..

Clearance details

Applicant: Pulmonary Medical Devices, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1988-04-05
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkley Heights, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.