THERMOSTATIC WATER MIXING VALVE TWV10— 510(k) K822874

Name: FDA 510(k) clearance K822874
Creator: U.S. Food and Drug Administration
Published: 1982-10-18

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K822874 for THERMOSTATIC WATER MIXING VALVE TWV10, Substantially Equivalent on 1982-10-18. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1982-09-27
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.