Innovative Health, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
50
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250305Reprocessed Agilis NxT Steerable IntroducerJanuary 7, 2026
K231015Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersJuly 1, 2024
K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterJune 7, 2024
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathApril 4, 2024
K230376Reprocessed Agilis NxT Steerable IntroducerAugust 7, 2023
K213584Reprocessed NRG Transseptal NeedleApril 4, 2023
K221854Reprocesses Umbilical CableAugust 6, 2022
K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterMay 25, 2022
K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathMarch 10, 2022
K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledDecember 20, 2021
K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterNovember 18, 2021
K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersSeptember 15, 2021
K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional May 4, 2021
K203261Reprocessed Inquiry Steerable Diagnostic EP CatheterMarch 5, 2021
K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterNovember 20, 2020
K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledSeptember 3, 2020
K200060Reprocessed NRG Transseptal NeedleJuly 30, 2020
K192998Reprocessed BRK Transseptal NeedleJuly 22, 2020
K193263Reprocessed Achieve Catheter Connecting CableJanuary 24, 2020
K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterDecember 11, 2019