BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET— 510(k) K925058

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K925058 for BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET, Substantially Equivalent on 1993-08-03. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1992-10-06
Decision date: 1993-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.