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Innovative Health, LLC

FDA 510(k) & PMA Approved Devices — 48 products

Total Devices48
Categories9
Latest FDA decision2024-07-01
TypeNumberDevice NameCodeDateActions
510(k) K231015 Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersNLI2024-07-01 View
510(k) K232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE2024-04-04 View
510(k) K230376 Reprocessed Agilis NxT Steerable IntroducerPNE2023-08-07 View
510(k) K213584 Reprocessed NRG Transseptal NeedleQLZ2023-04-04 View
510(k) K221854 Reprocesses Umbilical CableNLH2022-08-06 View
510(k) K210655 Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ2022-05-25 View
510(k) K212165 Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE2022-03-10 View
510(k) K212776 Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledNLG2021-12-20 View
510(k) K211662 Reprocessed IntellaMap Orion High Resolution Mapping CatheterNLG2021-11-18 View
510(k) K211276 Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersNLH2021-09-15 View
510(k) K203655 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)NLH2021-05-04 View
510(k) K203261 Reprocessed Inquiry Steerable Diagnostic EP CatheterDRF2021-03-05 View
510(k) K202042 Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterOWQ2020-11-20 View
510(k) K200212 Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledMTD2020-09-03 View
510(k) K200060 Reprocessed NRG Transseptal NeedleQLZ2020-07-30 View
510(k) K192998 Reprocessed BRK Transseptal NeedleNMK2020-07-22 View
510(k) K193263 Reprocessed Achieve Catheter Connecting CableNLH2020-01-24 View
510(k) K191880 Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterDRF2019-12-11 View
510(k) K191170 Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterNLH2019-10-30 View
510(k) K190127 Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterNLH2019-08-23 View

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