Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)— 510(k) K232013

Name: FDA 510(k) clearance K232013
Creator: U.S. Food and Drug Administration
Published: 2024-03-28

Substantially Equivalent

Goodman Co., Ltd.

FDA 510(k) clearance K232013 for Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040), Substantially Equivalent on 2024-03-28. Applicant: Goodman Co., Ltd.. Device class: 2.

Clearance details

Applicant: Goodman Co., Ltd.
Product code: Code PNO
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2023-07-06
Decision date: 2024-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNO

view all

More clearances from Goodman Co., Ltd.

view all

K010763 — GOODNET2001-05-25

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.