Submission Details
| 510(k) Number | K241478 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2024 |
| Decision Date | October 22, 2024 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Oct 2024
Decision
151d
Days
Class 2
Risk
About This 510(k) Submission
K241478 is an FDA 510(k) clearance for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on October 22, 2024, 151 days after receiving the submission on May 24, 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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