.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS— 510(k) K111295

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K111295 for .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS, Substantially Equivalent on 2011-05-31. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2011-05-10
Decision date: 2011-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.