FDA 510(k) Applications Submitted by Edwards Lifesciences, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K152980 |
10/09/2015 |
Flo Trac sensor, Volume View sensor |
Edwards Lifesciences, LLC |
| K211610 |
05/25/2021 |
Fogarty Occlusion Catheter |
Edwards Lifesciences, LLC |
| K191089 |
04/24/2019 |
Edwards Pressure Cable |
Edwards LifeSciences, LLC |
| K193466 |
12/16/2019 |
Swan-Ganz Catheters |
Edwards Lifesciences, LLC |
| K190205 |
02/04/2019 |
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module |
Edwards Lifesciences, LLC |
| K180881 |
04/04/2018 |
HemoSphere Advanced Monitor, HemoSphere Pressure Cable |
Edwards Lifesciences, LLC |
| K163381 |
12/01/2016 |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable |
Edwards Lifesciences, LLC |
| K192058 |
08/01/2019 |
EV1000 Clinical Platform NI, EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
| K182245 |
08/20/2018 |
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System |
Edwards Lifesciences, LLC |
| K172660 |
09/05/2017 |
Duravess bovine pericardial vascular patch |
Edwards Lifesciences, LLC |
| K203131 |
10/19/2020 |
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
| K190130 |
01/28/2019 |
The ClearSight finger cuffs |
Edwards Lifesciences, LLC |
| K160645 |
03/07/2016 |
PreSep Oligon Oximetry Catheter |
EDWARDS LIFESCIENCES, LLC |
| K152633 |
09/15/2015 |
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe |
EDWARDS LIFESCIENCES, LLC |
| K193179 |
11/18/2019 |
EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
| K230579 |
03/02/2023 |
Smart Wedge algorithm |
Edwards Lifesciences, LLC |
| K203224 |
11/02/2020 |
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform |
Edwards Lifesciences, LLC |
| K221528 |
05/26/2022 |
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter |
Edwards Lifesciences, LLC |
| K213682 |
11/22/2021 |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, A |
Edwards Lifesciences, LLC |
| K231038 |
04/12/2023 |
Global Hypoperfusion Index (GHI) Algorithm |
Edwards Lifesciences, LLC |
| K221704 |
06/13/2022 |
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) |
Edwards Lifesciences, LLC |
| K203490 |
11/27/2020 |
FORE-SIGHT ELITE Absolute Tissue Oximeter |
Edwards Lifesciences, LLC |
| K160084 |
01/15/2016 |
Swan Ganz Catheters |
Edwards Lifesciences, LLC |
| K171996 |
07/03/2017 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences, LLC |
| K223651 |
12/06/2022 |
Cerebral Adaptive Index (CAI) Algorithm |
Edwards Lifesciences, LLC |
| K223865 |
12/23/2022 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor |
Edwards Lifesciences, LLC |
| K160552 |
02/29/2016 |
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform |
EDWARDS LIFESCIENCES, LLC |
| K203687 |
12/17/2020 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index |
Edwards lifesciences, LLC |
| K193379 |
12/05/2019 |
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe |
Edwards Lifesciences, LLC |
| K181684 |
06/26/2018 |
VAMP Plus Venous/Arterial Blood Management Protection System |
Edwards Lifesciences, LLC |
| K173586 |
11/20/2017 |
VAMP Venous/Arterial Blood Management Protection System |
Edwards Lifesciences, LLC |
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