FDA 510(k)

HI-TORQUE PROCEED Guide Wire Family

K-Number: K201834 · 2020-07-30

Decision Date2020-07-30

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HI-TORQUE PROCEED Guide Wire Family is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2020-07-30 under approval number K201834. 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 PROCEED Guide Wire Family?

HI-TORQUE PROCEED Guide Wire Family is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Abbott Vascular. The 510(k) number is K201834.

When was HI-TORQUE PROCEED Guide Wire Family approved by the FDA?

HI-TORQUE PROCEED Guide Wire Family received FDA 510(k) clearance on 2020-07-30, under approval number K201834.

What company makes HI-TORQUE PROCEED Guide Wire Family?

HI-TORQUE PROCEED Guide Wire Family is manufactured by Abbott Vascular.

What is the FDA product code for HI-TORQUE PROCEED Guide Wire Family?

The FDA product code for HI-TORQUE PROCEED Guide Wire Family 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.