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FDA 510(k)

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

K-Number: K240997 · 2024-11-06

ApplicantABBOTT MEDICAL
Decision Date2024-11-06
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 2024-11-06 under approval number K240997. 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 2024-11-06. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K240997.

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 2024-11-06, under approval number K240997.

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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