K020028

Substantially Equivalent

6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX

Applicant: Boston Scientific
Product code: DQY
Advisory panel: Cardiovascular
Date received: 2002-01-04
Decision date: 2002-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, 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.