Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Reprocessed Intravascular Ultrasound Catheter

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Eagle Eye Platinum Rx Digital Ivus Catheter.

Pre-market Notification Details

Device IDK210655
510k NumberK210655
Device Name:Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
ClassificationReprocessed Intravascular Ultrasound Catheter
Applicant Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
ContactRick Ferreira
CorrespondentChristina Fleming
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
Product CodeOWQ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-04
Decision Date2022-05-25

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