FDA 510(k) Applications Submitted by Amy Oakes
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K223575 |
11/30/2022 |
Phoenix ICON, Phoenix ICON GO |
NeoLight, LLC |
| K170311 |
02/01/2017 |
Reprocessed Agilis NxT Steerable Introducer |
Innovative Health, LLC. |
| K170474 |
02/16/2017 |
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
| K170922 |
03/29/2017 |
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) |
Innovative Health, LLC. |
| K171277 |
05/01/2017 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K171503 |
05/23/2017 |
Reprocessed CristaCath Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K171788 |
06/15/2017 |
Reprocessed Halo XP Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K173262 |
10/11/2017 |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
Innovative Health, Llc. |
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