UltraScore Focused Force PTA Balloon— 510(k) K163420
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K163420 for UltraScore Focused Force PTA Balloon, Substantially Equivalent on 2017-06-14. Applicant: Bard Peripheral Vascular, Inc..
Clearance details
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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.