510(k) K213682
- Device
- HemoSphere Advanced Monitor Viewfinder Remote, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Software Feature, Acumen Assisted Fluid Management Software Feature With Acumen AFM Cable
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K213682
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-22
- Date received
- 2021-11-22
- 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
- Manthan Damani
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3022451073
- 3017401510
- 9615817
- 3003768277
- 3008717264
- 3032916632
- 8030978
- 3008452825
- 2184149
- 1018233
- 2134265
- 3004105270
- 3004091615
- 3012552532
- 3007208829
- 3012032144
- 1000165971
- 3013500228
- 3014848734
- 3000126629
- 3012528160
- 3012619193
- 1054713
- 3007734888
- 3017845286
- 3007029079
- 3016674095
- 3012811961
- 3001592626
- 3009254201
- 3013679558
- 9610105
- 3023164
- 3010716438
- 3002672225
- 1650907
- 3013300026
- 1000122786
- 3010155648
- 3012359877
- 3023272766
- 3019388613
- 2024168
- 2134213
- 3003144120
- 3008093809
- 3012154226
- 3007603826
- 1064858
- 3017233611
- 1224919
- 3017840980
- 3004016520
- 2124215
- 2183744
- 2133641
- 3009092139
- 2183715
- 2126666
- 1930027
- 3005334138
- 2031044
- 3003971136
- 3008203003
- 3014272734
- 3018783526
- 2438852
- 1316463
- 3030125003
- 1928237
- 3012179728
- 2183164
- 9615102
- 3032109181
- 3007184699
- 3026523691
- 3009499478
- 9617277
- 3020036682
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases