510(k) K223865
- Device
- 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
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K223865
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-09
- Date received
- 2022-12-23
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sara Pesian
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 9710602
- 3020036682
- 3017233611
- 3007734888
- 2029275
- 2135338
- 3008093809
- 3019388613
- 3012520654
- 3002672225
- 3008363989
- 3010157426
- 2952596
- 3014128039
- 3009443693
- 2133772
- 3012268816
- 8022257
- 3009499478
- 3004977335
- 2183164
- 3009600098
- 3012552532
- 3012154226
- 3010288146
- 3012260771
- 3021016555
- 2032112
- 3033558564
- 3008452825
- 3010705768
- 9681377
- 2438852
- 2126666
- 3013943846
- 3018783526
- 1018233
- 9611295
- 3010089768
- 3043479346
- 1928237
- 3007208829
- 3008203003
- 2182208
- 3012811961
- 2133641
- 3001592626
- 1064858
- 3003144120
- 1224919
- 3013596024
- 1721686
- 3013500228
- 3022435840
- 3012027770
- 2030404
- 3013679558
- 3000976525
- 9610816
- 3017401510
- 3008012314
- 3014848734
- 3017845286
- 3021769057
- 3023164
- 2134213
- 3010273872
- 3004105270
- 3000279201
- 3013403214
- 2124215
- 3031786139
- 3003616071
- 3013627970
- 3007029079
- 3012619193
- 3005877899
- 3008483389
- 3032916632
Source Documents#
Other 510(k) Records For Product Code DQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | 2026-02-17 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 |
| K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 2026-01-28 |
| K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 |