510(k) K163381
- Device
- HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K163381
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-14
- Date received
- 2016-12-01
- 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
- Chirag Shah
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3004091615
- 3005210579
- 9710602
- 3037724692
- 2134265
- 3006082230
- 8030978
- 3003768277
- 3017684005
- 1317188
- 2133641
- 3014579161
- 3021769057
- 3012520654
- 2648045
- 3013500228
- 3012811961
- 3045891669
- 1018233
- 3014271754
- 3012552532
- 3026740087
- 3008329188
- 3013557562
- 3017845286
- 3026523691
- 1224919
- 3007603826
- 3002672225
- 3007734888
- 3009831876
- 8022257
- 3010273872
- 2184149
- 3011353843
- 3007770164
- 3010705768
- 2183164
- 1218950
- 3000279201
- 1651104
- 3017401510
- 3004105270
- 2133772
- 2134213
- 2182208
- 2124215
- 1000165971
- 3033959233
- 3001763079
- 3016674095
- 3007208829
- 3007603855
- 3013627970
- 2183715
- 3008159616
- 3010157426
- 3012619193
- 3009254201
- 3045323923
- 2030404
- 3004415095
- 3013943846
- 2183744
- 3008729547
- 3043479346
- 3024821700
- 9610105
- 1721686
- 3003084417
- 3023272766
- 1930027
- 3032916632
- 3021016555
- 3012027770
- 1316463
- 2183926
- 1320894
- 3003971136
- 3022451073
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | 2026-10-01 |
| K261729 | EnSite™ X EP System | Abbott Medical | 2026-09-17 |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);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 | 2026-06-10 |
| 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 |
Legacy Summary#
summary
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