Emerge Monorail PTCA Dilatation Catheter— 510(k) K220629

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K220629 for Emerge Monorail PTCA Dilatation Catheter, Substantially Equivalent on 2022-03-24. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2022-03-04
Decision date: 2022-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.