PULM O2 SUCTION CATHETER TRAYS— 510(k) K953226

Substantially Equivalent

Premium Plastics, Inc.

FDA 510(k) clearance K953226 for PULM O2 SUCTION CATHETER TRAYS, Substantially Equivalent on 1995-08-08. Applicant: Premium Plastics, Inc..

Clearance details

Applicant: Premium Plastics, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1995-07-06
Decision date: 1995-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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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.