K040776

Substantially Equivalent

ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975

Applicant: Boston Scientific Corp
Product code: DQO
Advisory panel: Cardiovascular
Date received: 2004-03-26
Decision date: 2004-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.