Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter— 510(k) K191170
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K191170 for Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter, Substantially Equivalent on 2019-10-30. Applicant: Innovative Health, LLC.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code NLH
- 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.