510(k) K243944— Aperta NSE PTA Balloon Dilatation Catheter

Substantially Equivalent

Goodman Co., Ltd.

Clearance details

Applicant: Goodman Co., Ltd.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2024-12-20
Decision date: 2025-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

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.