SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM— 510(k) K062387

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K062387 for SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM, Substantially Equivalent on 2006-10-05. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2006-08-15
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, 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.