FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K222217 |
Abbott Medical |
ViewFlex Xtra Reprocessed ICE Catheter |
12/19/2022 |
K230934 |
Abbott Medical |
ViewFlexÖ Eco Reprocessed ICE Catheter |
05/03/2023 |
K231588 |
Abbott Medical |
ViewFlexÖ Eco Reprocessed ICE Catheter |
06/30/2023 |
K033436 |
ALLIANCE MEDICAL CORP. |
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER |
03/16/2005 |
K092425 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 |
10/21/2009 |
K063076 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER |
03/29/2007 |
K153090 |
INNOVATIVE HEALTH, LLC |
Reprocessed Diagnostic Ultrasound Catheter |
03/10/2016 |
K181126 |
Innovative Health, LLC |
Reprocessed Visions PV .035 Digital IVUS Catheter |
01/18/2019 |
K163560 |
Innovative Health, LLC. |
Reprocessed AcuNav Diagnostic Ultrasound Catheter |
07/12/2017 |
K210655 |
Innovative Health, LLC. |
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
05/25/2022 |
K170474 |
Innovative Health, LLC. |
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter |
06/16/2017 |
K173262 |
Innovative Health, Llc. |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
03/06/2018 |
K202042 |
Innovative Health, LLC. |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
11/20/2020 |
K223026 |
Northeast Scientific, Inc. |
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
02/03/2023 |
K110076 |
STERILMED, INC. |
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER |
08/18/2011 |
K012537 |
STERILMED, INC. |
REPROCESSED IMAGING CATHETERS |
10/11/2002 |
K190478 |
Sterilmed, Inc. |
Reprocessed ViewFlexÖ Xtra ICE Catheter |
11/14/2019 |
K161700 |
STERILMED, INC. |
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters |
11/21/2016 |
K043453 |
STERILMED, INC. |
STERILEMED REPROCESSED IVUS IMAGING CATHETER |
03/01/2005 |
K182238 |
Stryker Sustainability Solutions |
Reprocessed ViewFlex Xtra ICE Catheter |
05/08/2019 |
K231621 |
Stryker Sustainability Solutions |
Reprocessed ViewFlex Xtra ICE Catheter (D087031) |
07/25/2023 |
K121913 |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER |
12/20/2012 |
K230928 |
Vein 360 LLC |
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter |
08/25/2023 |
K230584 |
Vein 360 LLC |
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter |
06/06/2023 |