VALVE CONTROLLER FOR MICROMACRO COMPOUNDER— 510(k) K903159

Substantially Equivalent

Baxa Corp., Sub. of Cook Group, Inc.

FDA 510(k) clearance K903159 for VALVE CONTROLLER FOR MICROMACRO COMPOUNDER, Substantially Equivalent on 1990-11-07. Applicant: Baxa Corp., Sub. of Cook Group, Inc..

Clearance details

Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1990-07-18
Decision date: 1990-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.