2 CM PERIPHERAL CUTTING BALOON— 510(k) K041993

Substantially Equivalent

Boston Scientific Ivt

FDA 510(k) clearance K041993 for 2 CM PERIPHERAL CUTTING BALOON, Substantially Equivalent on 2004-08-16. Applicant: Boston Scientific Ivt.

Clearance details

Applicant: Boston Scientific Ivt
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2004-07-23
Decision date: 2004-08-16
Decision: Substantially Equivalent
Clearance type: Special
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.