FDA 510(k)

Heraeus TMW Guidewire

K-Number: K173052 · 2017-10-20

ApplicantHeraeus Medical Components, LLC

Decision Date2017-10-20

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Heraeus TMW Guidewire is a medical device manufactured by Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2017-10-20 under approval number K173052. 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 Heraeus TMW Guidewire?

Heraeus TMW Guidewire is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Heraeus Medical Components, LLC. The 510(k) number is K173052.

When was Heraeus TMW Guidewire approved by the FDA?

Heraeus TMW Guidewire received FDA 510(k) clearance on 2017-10-20, under approval number K173052.

What company makes Heraeus TMW Guidewire?

Heraeus TMW Guidewire is manufactured by Heraeus Medical Components, LLC.

What is the FDA product code for Heraeus TMW Guidewire?

The FDA product code for Heraeus TMW Guidewire is DQX.

Other Devices by Heraeus Medical Components, LLC

K170664Odyssey Micro Catheter K191305Hereaeus Poseidon Microcatheter K191502Heraeus Peripheral Guidewire

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Official Source

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