FDA 510(k)

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

K-Number: K240997 · 2024-11-06

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 the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-11-06 under 510(k) 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. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K240997.

When did Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire receive FDA 510(k) clearance?

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 510(k) number K240997.

Who is the listed applicant for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.