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 the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2017-10-20 under 510(k) 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. The listed applicant is Heraeus Medical Components, LLC. The 510(k) number is K173052.

When did Heraeus TMW Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for Heraeus TMW Guidewire?

The FDA 510(k) record lists Heraeus Medical Components, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heraeus TMW Guidewire?

The FDA product code for Heraeus TMW Guidewire is DQX.

Other records listing Heraeus Medical Components, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191305Hereaeus Poseidon Microcatheter K191502Heraeus Peripheral Guidewire K170664Odyssey Micro Catheter

Related Devices (Code: DQX)

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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.