FDA 510(k) Applications Submitted by Edwards LifeSciences
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K241330 |
05/10/2024 |
Fogarty Fortis Arterial Embolectomy Catheter |
Edwards Lifesciences |
| K233619 |
11/13/2023 |
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters |
Edwards Lifesciences |
| K244046 |
12/30/2024 |
Edwards eSheath Optima introducer set |
Edwards Lifesciences |
| K233983 |
12/18/2023 |
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) |
Edwards Lifesciences |
| K153069 |
10/22/2015 |
Edwards Balloon Catheter |
EDWARDS LIFESCIENCES |
| K240596 |
03/04/2024 |
Cerebral Autoregulation Index (CAI) Algorithm |
Edwards Lifesciences |
| K152225 |
08/07/2015 |
Edwards eSheath Introducer Set |
EDWARDS LIFESCIENCES |
| DEN190029 |
06/03/2019 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences |
| K110597 |
03/02/2011 |
EV1000 CLINICAL PLATFORM |
EDWARDS LIFESCIENCES |
| K141696 |
06/24/2014 |
EDWARDS ESHEATH INTRODUCER SET |
EDWARDS LIFESCIENCES |
| K233895 |
12/11/2023 |
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and |
Edwards Lifesciences |
| K142199 |
08/11/2014 |
Ascendra Balloon Aortic Valvaloplasty Catheter |
EDWARDS LIFESCIENCES |
| K242451 |
08/16/2024 |
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) |
Edwards LifeSciences |
| K243781 |
12/09/2024 |
HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HE |
Edwards Lifesciences |
| K200258 |
02/03/2020 |
Edwards eSheath Introducer Set |
Edwards Lifesciences |
| K233820 |
12/01/2023 |
Fogarty Arterial Embolectomy Catheter with Gate Valve |
Edwards Lifesciences |
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