Serranator PTA Serration Balloon Catheter— 510(k) K203437
Substantially EquivalentCagent Vascular, LLC
FDA 510(k) clearance K203437 for Serranator PTA Serration Balloon Catheter, Substantially Equivalent on 2020-12-22. Applicant: Cagent Vascular, LLC.
Clearance details
- Applicant
- Cagent Vascular, LLC
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wayne, PA, 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.