ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP— 510(k) K081905

Substantially Equivalent

Westmed, Inc.

FDA 510(k) clearance K081905 for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP, Substantially Equivalent on 2008-07-15. Applicant: Westmed, Inc..

Clearance details

Applicant: Westmed, Inc.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2008-07-03
Decision date: 2008-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highlands Ranch, CO, US

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.