GAMBRO PUMP CONSOLE CSL— 510(k) K822068

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K822068 for GAMBRO PUMP CONSOLE CSL, Substantially Equivalent on 1982-08-24. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1982-07-14
Decision date: 1982-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.