Confirm Rx Insertable Cardiac Monitor (ICM) System
FDA 510(k) K163407 · St. Jude Medical, Inc.
510(k) numberK163407
Submission
- Device name
- Confirm Rx Insertable Cardiac Monitor (ICM) System
- Applicant
- St. Jude Medical, Inc.
Sylmar, CA, US - Received
- December 5, 2016
- Decision date
- September 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXC – Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230286 | Assert-IQ Insertable Cardiac MonitorMXC · Traditional | Abbott Medical | 05/17/2023SE |
| K212206 | Jot Dx Insertable Cardiac MonitorMXC · Special | Abbott (St. Jude Medical) | 08/13/2021SE |
| K202876 | Confirm Rx Insertable Cardiac MonitorMXC · Special | Abbott (St. Jude Medical) | 12/01/2020SE |
| K202888 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | Abbott (St. Jude Medical) | 11/23/2020SE |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)MXC · Traditional | Abbott (St. Jude Medical) | 03/17/2020SE |
| K192593 | Confirm Rx Insertable Cardiac MonitorMXC · Special | Abbott | 10/18/2019SE |
| K190295 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | Abbott (St. Jude Medical) | 04/10/2019SE |
| K182981 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | Abbott | 03/29/2019SE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001MXC · Special | St Jude Medical | 11/02/2017SE |
| K133481 | SJM Confirm Implantable Cardiac Monitor (Icm)MXC · Traditional | St. Jude Medical, Inc. | 05/28/2014SE |
More from St. Jude Medical, 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 |
| 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 |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0DQK · Traditional | 10/21/2016SE |
Questions and answers
When was Confirm Rx Insertable Cardiac Monitor (ICM) System cleared by the FDA?
Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 298 days after the submission was received.
What is the product code of K163407?
The FDA product code is MXC – Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection), a Class II (moderate risk) device regulated under 21 CFR 870.2800.