Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile— 510(k) K181828
Substantially EquivalentScientia Vascular, LLC
FDA 510(k) clearance K181828 for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile, Substantially Equivalent on 2018-08-07. 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.