510(k) K212776
- Device
- Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- Applicant
- Innovative Health, LLC
- 510(k) number
- K212776
- Product code
- NLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-20
- Date received
- 2021-09-01
- Regulation
- 870.1220
- Classification name
- Catheter, Intracardiac Mapping, High-Density, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Rick Ferreira
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257
FDA Registration Numbers
- 3011024991
- 3011276773
- 3011610434
- 2183744
- 3009888344
- 2032112