FreedomFlow™ Orbital Circumferential Atherectomy System (K242947)
Description
FreedomFlow™ Orbital Circumferential Atherectomy System by Cardio Flow Inc.,, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242947
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. FreedomFlow™ Orbital Circumferential Atherectomy System (K242947) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H60... | Cardio Flow Inc., | 2024 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6... | Cardio Flow Inc., | 2025 |
Trace the full predicate network for K242947
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.