Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter— 510(k) K210655
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K210655 for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, Substantially Equivalent on 2022-05-25. Applicant: Innovative Health, LLC.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code OWQ
- 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.