BARD PLAQUE ELECTRODE ARRAY— 510(k) K893611

Substantially Equivalent

Bard Electrophysiology

FDA 510(k) clearance K893611 for BARD PLAQUE ELECTRODE ARRAY, Substantially Equivalent on 1989-07-14. Applicant: Bard Electrophysiology.

Clearance details

Applicant: Bard Electrophysiology
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1989-05-10
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.