Tri-Wedge PTA Scoring Balloon Dilatation Catheter— 510(k) K241478
Substantially EquivalentBrosmed Medical Co., Ltd.
FDA 510(k) clearance K241478 for Tri-Wedge PTA Scoring Balloon Dilatation Catheter, Substantially Equivalent on 2024-10-22. Applicant: Brosmed Medical Co., Ltd..
Clearance details
- Applicant
- Brosmed Medical Co., Ltd.
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Adverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . 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.