Submission Details
| 510(k) Number | K243944 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2024 |
| Decision Date | April 22, 2025 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Aperta NSE PTA Balloon Dilatation Catheter
Apr 2025
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K243944 is an FDA 510(k) clearance for the Aperta NSE PTA Balloon Dilatation Catheter, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Goodman Co., Ltd. (Nagoya, JP). The FDA issued a Cleared decision on April 22, 2025, 123 days after receiving the submission on December 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | PNO — Catheter, Percutaneous, Cutting/scoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material |
Manufacturer
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