FDA.reportPublic FDA data

INNOVATIVE HEALTH, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116104343011610434INNOVATIVE HEALTH, LLC.1N2027-01-011435 N. Hayden Road Suite 100 Scottsdale AZ US 85257

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1809711797582260K250305Reprocessed Agilis NxT Steerable IntroducerPNE2026-01-07
1809711548041793K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH2024-06-07
1809711609668969K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE2024-04-04
1809711416707446K221854Reprocesses Umbilical CableNLH2022-08-06
1809712019048629K213584Reprocessed NRG Transseptal NeedleQLZ2023-04-04
1809711477120562K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledNLG2021-12-20
1809711489141469K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE2022-03-10
1809711302227654K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterNLG2021-11-18
1809711555900278K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersNLH2021-09-15
1809711434342219K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ2022-05-25
1809711882888778K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)NLH2021-05-04
1809711783761145K203261Reprocessed Inquiry Steerable Diagnostic EP CatheterDRF2021-03-05
1809711333642071K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterOWQ2020-11-20
1809711848352640K200060Reprocessed NRG Transseptal NeedleQLZ2020-07-30
1809711304918921K193263Reprocessed Achieve Catheter Connecting CableNLH2020-01-24
1809711794486655K192998Reprocessed BRK Transseptal NeedleNMK2020-07-22
1809711856916778K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterDRF2019-12-11
1809711445348805K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterNLH2019-10-30
1809711346207964K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterDRF2019-07-01
1809711978520064K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterNLG2019-06-25
1809711227659672K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterNLH2019-08-23
1809711015555254K182488Reprocessed Response Diagnostic Electrophysiology CatheterNLH2019-02-22
1809711774174561K182386Reprocessed Supreme Diagnostic Electrophysiology CatheterDRF2019-04-23
1809711622825265K181897Reprocessed Marinr Diagnostic EP CatheterNLH2018-11-15
1809712005833199K181618Reprocessed Torqr Diagnostic EP CatheterNLH2018-10-18
1809711722067165K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterNLH2018-10-27
1809711942815183K180710Reprocessed DecaNav Diagnostic Electrophysiology CatheterNLH2018-06-19
1809711760716148K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterOWQ2018-03-06
1809711037652641K171788Reprocessed Halo XP Diagnostic Electrophysiology CatheterNLH2017-11-03
1809711837193673K171503Reprocessed CristaCath Diagnostic Electrophysiology CatheterNLH2017-10-05
1809711906857974K171277Reprocessed Inquiry Steerable Diagnostic EP CatheterDRF2017-10-23
1809711358850411K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)NLH2017-06-22
1809712024587574K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterOWQ2017-06-16
1809711190999080K170311Reprocessed Agilis NxT Steerable IntroducerPNE2017-06-02
1809711439720211K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterOWQ2017-07-12
1809711661940803K162251Reprocessed Viking Diagnostic Electrophysiology CathetersNLH2016-12-21
1809711613660482K161827Reprocessed Response Diagnostic Electrophysiology CathetersNLH2016-12-08
1809711434650927K161769Reprocessed Supreme Diagnostic Electrophysiology CathetersDRF2016-12-06
1809712039796182K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersNLH2016-09-30
1809711289765037K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterNLH2016-10-26
1809711545517526K160496Reprocessed Inquiry Steerable Diagnostic EP CatheterNLH2016-06-10
1809711809170402K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterNLH2016-11-02
1809711933052108K160303Reprocessed Polaris X Steerable Diagnostic EP CatheterNLH2016-05-10
1809711044568962K160242Reprocessed Livewire Steerable Diagnostic EP CatheterNLH2016-05-10
1809711610808140K153153Reprocessed Electrophysiology CatheterNLH2016-03-14
1809711736074914K153090Reprocessed Diagnostic Ultrasound CatheterOWQ2016-03-10
1809711124759546
1809711754245983
1809712016191876

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NLH242024-06-07
OWQ62022-05-25
DRF62021-03-05
PNE42026-01-07
NLG32021-12-20
QLZ22023-04-04
NMK12020-07-22