Innovative Health, LLC - FDA 510(k) Cleared Devices
Recent clearances: Reprocessed BRK Transseptal Needle, Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters, Reprocessed VersaCross Steerable Sheath
49
Total
49
Cleared
0
Denied
FDA 510(k) Regulatory Record - Innovative Health, LLC Cardiovascular ✕
49 devices
Cleared
Oct 19, 2026
Reprocessed BRK Transseptal Needle
Cardiovascular
60d
Cleared
Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
Cardiovascular
448d
Cleared
Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
Cardiovascular
269d
Cleared
Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
Cardiovascular
175d
Cleared
Apr 04, 2023
Reprocessed NRG Transseptal Needle
Cardiovascular
508d
Cleared
Aug 06, 2022
Reprocesses Umbilical Cable
Cardiovascular
40d
Cleared
May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Cardiovascular
447d
Cleared
Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
Cardiovascular
241d
Cleared
Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Cardiovascular
110d
Cleared
Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Cardiovascular
170d
Cleared
Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Cardiovascular
141d
Cleared
May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
Cardiovascular
140d
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