Class Class II
Assert-IQ™ Insertable Cardiac Monitor (K230286)
Description
Assert-IQ™ Insertable Cardiac Monitor by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230286
Clearance Date2023-05-17
Clearance TypeTraditional
Product CodeMXC
Regulation Number870.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230286
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Assert-IQ™ Insertable Cardiac Monitor (K230286) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021 |
Trace the full predicate network for K230286
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.