Reprocessed Orbiter ST Steerable Diagnostic EP Catheter— 510(k) K161393
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K161393 for Reprocessed Orbiter ST Steerable Diagnostic EP Catheter, Substantially Equivalent on 2016-10-26. 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.