Class Class II

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552)

K250552 2025-07-25 Traditional
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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

Device ClassClass Class II
510(k) NumberK250552
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeDQX
Regulation Number870.1330

Categories

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Predicate lineage for K250552

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 (K250552) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14...ABBOTT MEDICAL2024

Trace the full predicate network for K250552

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.

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