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.
|Device Name:||Reprocessed Dynamic Tip And XT Steerable Diagnostic Electrophysiology Catheters|
|Classification||Catheter, Recording, Electrode, Reprocessed|
|Applicant||Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257|
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257
|CFR Regulation Number||870.1220 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|