Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828)
Description
Affera Integrated Mapping System; Impedance Localization Patch Kit by Medtronic, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241828
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. Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828) cites 2 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch... | Medtronic, Inc. | 2024 |
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precis... | ABBOTT MEDICAL | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 |
| K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 |
Trace the full predicate network for K241828
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.