Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire— 510(k) K220398
Substantially EquivalentScientia Vascular, LLC
FDA 510(k) clearance K220398 for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire, Substantially Equivalent on 2023-03-10. Applicant: Scientia Vascular, LLC.
Clearance details
- Applicant
- Scientia Vascular, LLC
- Product code
- Code MOF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Adverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
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.