Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
Innovative Health, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1645361 | 1000117853 | INNOVATIVE HEALTHCARE CORPORATION | 1 | Y | 2026-01-01 | 8220 CHARLES PAGE BLVD SAND SPRINGS OK US 74063 |
| 3011610434 | 3011610434 | INNOVATIVE HEALTH, LLC. | 1 | N | 2026-01-01 | 1435 N. Hayden Road Suite 100 Scottsdale AZ US 85257 |
| 3018229072 | 3018229072 | INNOVATIVE HEALTH SCIENCES | 1 | N | 2026-01-01 | 1108 Kings Hwy Suite 4 Chester NY US 10918 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10841898113413 | N/A - Response Diagnostic EP Catheter, 6F | 877-400-3740 | regulatory@innovative-health.com |
| 10841898120244 | N/A - Agilis NxT Steerable Introducer, 61 cm | 877-400-3740 | regulatory@innovative-health.com |
| 10841898120251 | N/A - Agilis NxT Steerable Introducer, 61 cm | 877-400-3740 | regulatory@innovative-health.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 180971 | 1797582260 | K250305 | Reprocessed Agilis NxT Steerable Introducer | PNE | 2026-01-07 |
| 180971 | 1548041793 | K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | NLH | 2024-06-07 |
| 299991 | 1341997840 | K232328 | Insignis™ Syringe Infusion System | FPA | 2024-03-01 |
| 180971 | 1609668969 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | PNE | 2024-04-04 |
| 180971 | 1416707446 | K221854 | Reprocesses Umbilical Cable | NLH | 2022-08-06 |
| 180971 | 2019048629 | K213584 | Reprocessed NRG Transseptal Needle | QLZ | 2023-04-04 |
| 180971 | 1477120562 | K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | NLG | 2021-12-20 |
| 180971 | 1489141469 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | PNE | 2022-03-10 |
| 180971 | 1302227654 | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | NLG | 2021-11-18 |
| 180971 | 1555900278 | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | NLH | 2021-09-15 |
| 180971 | 1434342219 | K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | 2022-05-25 |
| 180971 | 1882888778 | K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | 2021-05-04 |
| 180971 | 1783761145 | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | DRF | 2021-03-05 |
| 299991 | 1921964942 | K202279 | Insignis Subcutaneous Needle Sets | FPA | 2021-08-13 |
| 180971 | 1333642071 | K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | OWQ | 2020-11-20 |
| 180971 | 1848352640 | K200060 | Reprocessed NRG Transseptal Needle | QLZ | 2020-07-30 |
| 180971 | 1304918921 | K193263 | Reprocessed Achieve Catheter Connecting Cable | NLH | 2020-01-24 |
| 180971 | 1794486655 | K192998 | Reprocessed BRK Transseptal Needle | NMK | 2020-07-22 |
| 180971 | 1856916778 | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | DRF | 2019-12-11 |
| 180971 | 1445348805 | K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | NLH | 2019-10-30 |
| 180971 | 1346207964 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | DRF | 2019-07-01 |
| 180971 | 1978520064 | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | NLG | 2019-06-25 |
| 180971 | 1227659672 | K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | NLH | 2019-08-23 |
| 180971 | 1015555254 | K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | NLH | 2019-02-22 |
| 180971 | 1774174561 | K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | DRF | 2019-04-23 |
| 180971 | 1622825265 | K181897 | Reprocessed Marinr Diagnostic EP Catheter | NLH | 2018-11-15 |
| 180971 | 2005833199 | K181618 | Reprocessed Torqr Diagnostic EP Catheter | NLH | 2018-10-18 |
| 180971 | 1722067165 | K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | NLH | 2018-10-27 |
| 180971 | 1942815183 | K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | NLH | 2018-06-19 |
| 180971 | 1760716148 | K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | OWQ | 2018-03-06 |
| 180971 | 1037652641 | K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | NLH | 2017-11-03 |
| 180971 | 1837193673 | K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | NLH | 2017-10-05 |
| 180971 | 1906857974 | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | DRF | 2017-10-23 |
| 180971 | 1358850411 | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | 2017-06-22 |
| 180971 | 2024587574 | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | OWQ | 2017-06-16 |
| 180971 | 1190999080 | K170311 | Reprocessed Agilis NxT Steerable Introducer | PNE | 2017-06-02 |
| 180971 | 1439720211 | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | OWQ | 2017-07-12 |
| 180971 | 1661940803 | K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters | NLH | 2016-12-21 |
| 180971 | 1613660482 | K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters | NLH | 2016-12-08 |
| 180971 | 1434650927 | K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters | DRF | 2016-12-06 |
| 180971 | 2039796182 | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | NLH | 2016-09-30 |
| 180971 | 1289765037 | K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | NLH | 2016-10-26 |
| 180971 | 1545517526 | K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | NLH | 2016-06-10 |
| 180971 | 1809170402 | K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter | NLH | 2016-11-02 |
| 180971 | 1933052108 | K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | NLH | 2016-05-10 |
| 180971 | 1044568962 | K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter | NLH | 2016-05-10 |
| 180971 | 1610808140 | K153153 | Reprocessed Electrophysiology Catheter | NLH | 2016-03-14 |
| 180971 | 1736074914 | K153090 | Reprocessed Diagnostic Ultrasound Catheter | OWQ | 2016-03-10 |
| 180971 | 1124759546 | ||||
| 180971 | 1754245983 | ||||
| 180971 | 2016191876 |
Innovative Health, LLC
Innovative Health
Innovative Health, LLC
Innovative Health Sciences, LLC
Innovative Health Technologies (Nz), Ltd.
Innovative Health, LLC
Innovative Health, LLC
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health Sciences, LLC
Innovative Health, LLC
Innovative Health, LLC.
Innovative Health, LLC
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, Llc.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
Innovative Health, LLC.
2019-03-06
2018-05-01
2017-10-16
2017-10-16
2017-10-16
2019-02-02
2019-02-02
2017-03-14
2017-10-16
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2017-10-16
2017-03-14
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2017-05-10
2018-08-21
2017-06-29
2017-03-14
2018-08-21
2017-10-16
2017-03-14
2018-08-21
2017-10-16
2017-06-29
2018-04-30
2017-10-16
2017-03-14
2017-10-16
2017-06-29
2018-05-18
2017-06-20
2017-10-16
2017-03-14
2018-04-30
2017-06-29
2017-10-16
2018-05-01
2017-03-03
2017-03-14
2018-05-18
2018-11-12