Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
FDA 510(k) K160187 · St Jude Medical
510(k) numberK160187
Submission
- Device name
- Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
- Applicant
- St Jude Medical
St. Paul, MN, US - Received
- January 27, 2016
- Decision date
- October 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | 07/20/2018SE |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2DQK · Traditional | 04/23/2018SE |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | 04/23/2018SE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001MXC · Special | 11/02/2017SE |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC · Traditional | 09/29/2017SE |
| K162643 | MediGuide Technology SystemDQK · Traditional | 12/13/2016SE |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | 12/13/2016SE |
| K160218 | AutoMark ModuleDQK · Traditional | 12/13/2016SE |
| K160210 | EnSite Precision Cardiac Mapping System v2.0DQK · Traditional | 12/13/2016SE |
| K161873 | Pacel Flow Directed Pacing CatheterLDF · Traditional | 11/22/2016SE |
Questions and answers
When was Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 cleared by the FDA?
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (K160187) received a 510(k) decision of Substantially Equivalent on October 21, 2016, 268 days after the submission was received.
What is the product code of K160187?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.