Class Class II
Rotarex Atherectomy System (K242757)
Description
Rotarex Atherectomy System by Bard Peripheral Vascular, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242757
Clearance Date2025-01-30
Clearance TypeSpecial
Product CodeMCW
Regulation Number870.4875
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242757
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. Rotarex Atherectomy System (K242757) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211738 | Rotarex Atherectomy System | C.R. Bard, Inc. | 2021 |
Trace the full predicate network for K242757
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.