2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter— 510(k) K151253

Substantially Equivalent

Boston Scientific Limited

FDA 510(k) clearance K151253 for 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter, Substantially Equivalent on 2015-06-10. Applicant: Boston Scientific Limited.

Clearance details

Applicant: Boston Scientific Limited
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2015-05-12
Decision date: 2015-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

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.