SUCTION SET, TRACHAEL— 510(k) K935583

Unknown

Puritas Health Care, Inc.

FDA 510(k) clearance K935583 for SUCTION SET, TRACHAEL, Unknown on 1994-04-11. Applicant: Puritas Health Care, Inc..

Clearance details

Applicant: Puritas Health Care, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1993-11-18
Decision date: 1994-04-11
Decision: Unknown
Clearance type: Traditional
Location: New Milford, CT, 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.