Assert-IQ Insertable Cardiac Monitor
FDA 510(k) K230286 · Abbott Medical
510(k) numberK230286
Submission
- Device name
- Assert-IQ Insertable Cardiac Monitor
- Applicant
- Abbott Medical
Sylmar, CA, US - Received
- February 2, 2023
- Decision date
- May 17, 2023
- 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 |
|---|---|---|---|
| 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 |
| K133481 | SJM Confirm Implantable Cardiac Monitor (Icm)MXC · Traditional | St. Jude Medical, Inc. | 05/28/2014SE |
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| K253516 | Assert-IQ (DM5100)MXD · Special | 12/18/2025SE |
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Questions and answers
When was Assert-IQ Insertable Cardiac Monitor cleared by the FDA?
Assert-IQ Insertable Cardiac Monitor (K230286) received a 510(k) decision of Substantially Equivalent on May 17, 2023, 104 days after the submission was received.
What is the product code of K230286?
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.