510(k) K881770
- Device
- EPICARDIA LE/FD
- Applicant
- MEDICOMP, INC.
- 510(k) number
- K881770
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-31
- Date received
- 1988-04-26
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOE RIFFE
- Address
- 7845 Ellis Rd. West Melbourne FL US 32904 32904
FDA Registration Numbers#
- 3003084417
- 3014272734
- 3013557562
- 3003144120
- 3014128039
- 3008717264
- 3008012314
- 2183715
- 3008729547
- 3008159616
- 3016406615
- 3012811961
- 3012032144
- 2182208
- 3022780114
- 3026523691
- 9615817
- 3016674095
- 3017233611
- 2124215
- 1218950
- 9710602
- 3021016555
- 1721686
- 3010157426
- 3013943846
- 2184149
- 3022435840
- 3008452825
- 1651104
- 3018783526
- 1219324
- 3008093809
- 3018940143
- 3003616071
- 1018233
- 9681377
- 1058584
- 3021769057
- 3008203003
- 3012528160
- 1319660
- 3010390468
- 3007184699
- 3022451073
- 3008363989
- 2133641
- 2135338
- 3007137685
- 9610816
- 3026740087
- 2438852
- 2133810
- 3010273872
- 1650907
- 3023272766
- 3033959233
- 8022257
- 3045498928
- 3010342616
- 3001763079
- 3017060084
- 2183744
- 9611295
- 1000165971
- 8030978
- 3007603855
- 2032112
- 3009092139
- 3006082230
- 3032109181
- 3014579161
- 9673241
- 9610105
- 3007029079
- 3016701404
- 3010728615
- 3017840980
- 3007208829
- 3012027770
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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