Reprocessed Dynamic Tip And XT Steerable Diagnostic Electrophysiology Catheters

Catheter, Recording, Electrode, Reprocessed

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Dynamic Tip And Xt Steerable Diagnostic Electrophysiology Catheters.

Pre-market Notification Details

Device IDK211276
510k NumberK211276
Device Name:Reprocessed Dynamic Tip And XT Steerable Diagnostic Electrophysiology Catheters
ClassificationCatheter, Recording, Electrode, Reprocessed
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 CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-27
Decision Date2021-09-15

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