FDA 510(k)

HI-TORQUE Steelcore Bare Guide Wire

K-Number: K200144 · 2020-04-08

Decision Date2020-04-08

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HI-TORQUE Steelcore Bare Guide Wire is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2020-04-08 under approval number K200144. 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 Steelcore Bare Guide Wire?

HI-TORQUE Steelcore Bare Guide Wire is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by Abbott Vascular. The 510(k) number is K200144.

When was HI-TORQUE Steelcore Bare Guide Wire approved by the FDA?

HI-TORQUE Steelcore Bare Guide Wire received FDA 510(k) clearance on 2020-04-08, under approval number K200144.

What company makes HI-TORQUE Steelcore Bare Guide Wire?

HI-TORQUE Steelcore Bare Guide Wire is manufactured by Abbott Vascular.

What is the FDA product code for HI-TORQUE Steelcore Bare Guide Wire?

The FDA product code for HI-TORQUE Steelcore Bare 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.