PRUITT ARTERIAL OCCLUSION CHOLANG. CATH— 510(k) K812111

Substantially Equivalent

Bionomy, Inc.

FDA 510(k) clearance K812111 for PRUITT ARTERIAL OCCLUSION CHOLANG. CATH, Substantially Equivalent on 1981-11-16. Applicant: Bionomy, Inc..

Clearance details

Applicant: Bionomy, Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1981-07-27
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.