PERIPHERAL CUTTING BALLOON— 510(k) K040155

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K040155 for PERIPHERAL CUTTING BALLOON, Substantially Equivalent on 2004-07-01. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2004-01-23
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.