Reprocessed Achieve Catheter Connecting Cable

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 Achieve Catheter Connecting Cable.

Pre-market Notification Details

Device IDK193263
510k NumberK193263
Device Name:Reprocessed Achieve Catheter Connecting Cable
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
ContactRick Ferreira
CorrespondentAmanda Babock
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
Product CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-01-24
Summary:summary

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.