USCI BIPOLAR BALLON PACING ELECTRODE— 510(k) K800298

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K800298 for USCI BIPOLAR BALLON PACING ELECTRODE, Substantially Equivalent on 1980-04-16. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1980-02-11
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.