FDA.reportPublic FDA data

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

Applicant Contact#

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NLG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC2021-11-18
K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC2019-06-25