Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997)
Description
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240997
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. Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201834 | HI-TORQUE PROCEED Guide Wire Family | Abbott Vascular | 2020 |
| K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | Abbott Vascular, Inc. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14... | ABBOTT MEDICAL | 2025 |
Trace the full predicate network for K240997
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.