Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter— 510(k) K160421
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K160421 for Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter, Substantially Equivalent on 2016-11-02. 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.