Reprocessed IntellaMap Orion High Resolution Mapping Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Intellamap Orion High Resolution Mapping Catheter.

Pre-market Notification Details

Device IDK211662
510k NumberK211662
Device Name:Reprocessed IntellaMap Orion High Resolution Mapping Catheter
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
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 CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2021-11-18

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