SJM Confirm Implantable Cardiac Monitor
FDA 510(k) K122090 · St. Jude Medical, Cardiac Rhythm Management Divisi
510(k) numberK122090
Submission
- Device name
- SJM Confirm Implantable Cardiac Monitor
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
Sylmar, CA, US - Received
- July 16, 2012
- Decision date
- November 15, 2012
- 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 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC · Traditional | St. Jude Medical, Inc. | 09/29/2017SE |
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| K111943 | Agills PF Delivery SystemDYB · Traditional | 09/29/2011SE |
| K103250 | CPS Direct SL II Slittable Outer CatheterDQY · Special | 01/19/2011SE |
| K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ADSA · Traditional | 04/02/2010SE |
| K092075 | CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004…DQY · Special | 08/07/2009SE |
| K090613 | CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59…DQY · Special | 07/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | 04/30/2008SE |
| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | 03/13/2008SE |
Questions and answers
When was SJM Confirm Implantable Cardiac Monitor cleared by the FDA?
SJM Confirm Implantable Cardiac Monitor (K122090) received a 510(k) decision of Substantially Equivalent on November 15, 2012, 122 days after the submission was received.
What is the product code of K122090?
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.