ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014— 510(k) K050577

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K050577 for ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014, Substantially Equivalent on 2005-03-30. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2005-03-07
Decision date: 2005-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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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.