BARD PCA II PUMP WITH PROGRAM CARTRIDGES— 510(k) K914502

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K914502 for BARD PCA II PUMP WITH PROGRAM CARTRIDGES, Substantially Equivalent on 1991-12-18. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 1991-10-09
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

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Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.