USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING— 510(k) K955712

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K955712 for USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING, Substantially Equivalent on 1996-10-11. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1995-12-15
Decision date: 1996-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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.