BRONCHITRAC DF DUAL RESP/CATHETER— 510(k) K833633

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K833633 for BRONCHITRAC DF DUAL RESP/CATHETER, Substantially Equivalent on 1983-12-08. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1983-10-17
Decision date: 1983-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.