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FDA 510(k)

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

K-Number: K250552 · 2025-07-25

ApplicantABBOTT MEDICAL
Decision Date2025-07-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-07-25 under approval number K250552. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K250552.

When was Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire approved by the FDA?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire received FDA 510(k) clearance on 2025-07-25, under approval number K250552.

What company makes Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

The FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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