BURRON PERCUTANEOUS INDUCER SET— 510(k) K810460

Substantially Equivalent

Burron Medical Products, Inc.

FDA 510(k) clearance K810460 for BURRON PERCUTANEOUS INDUCER SET, Substantially Equivalent on 1981-03-11. Applicant: Burron Medical Products, Inc..

Clearance details

Applicant: Burron Medical Products, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1981-02-20
Decision date: 1981-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.