EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
FDA 510(k) K182644 · Abbott
510(k) numberK182644
Submission
- Device name
- EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
- Applicant
- Abbott
St. Paul, MN, US - Received
- September 24, 2018
- Decision date
- October 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
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| K222297 | CentriMag Pre-connected PackDTZ · Traditional | 12/01/2022SE |
| K221213 | EnSite X EP SystemDQK · Traditional | 08/18/2022SE |
| K212061 | EnSite X EP SystemDQK · Traditional | 10/22/2021SE |
| K210392 | WorkMate Claris SystemDQK · Special | 03/11/2021SE |
| K192593 | Confirm Rx Insertable Cardiac MonitorMXC · Special | 10/18/2019SE |
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Questions and answers
When was EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 cleared by the FDA?
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644) received a 510(k) decision of Substantially Equivalent on October 19, 2018, 25 days after the submission was received.
What is the product code of K182644?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.