Reprocessed Carto Vizigo Bi-Directional Guiding Sheath— 510(k) K212165
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K212165 for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath, Substantially Equivalent on 2022-03-10. Applicant: Innovative Health, LLC.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code PNE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.