Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter— 510(k) K181458
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K181458 for Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter, Substantially Equivalent on 2018-10-27. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.