Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Catheter, Intracardiac Mapping, High-density Array

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Advisor Hd Grid Mapping Catheter, Sensor Enabled.

Pre-market Notification Details

Device IDK200212
510k NumberK200212
Device Name:Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
ClassificationCatheter, Intracardiac Mapping, High-density Array
Applicant Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
ContactRick Ferreira
CorrespondentAmanda Babcock
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
Product CodeMTD  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-28
Decision Date2020-09-03

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