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FDA 510(k)

PW Guidewires

K-Number: K152497 · 2016-01-22

ApplicantTatara Vascular, LLC
Decision Date2016-01-22
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PW Guidewires is a medical device manufactured by Tatara Vascular, LLC. It received FDA 510(k) clearance on 2016-01-22 under approval number K152497. 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 PW Guidewires?

PW Guidewires is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Tatara Vascular, LLC. The 510(k) number is K152497.

When was PW Guidewires approved by the FDA?

PW Guidewires received FDA 510(k) clearance on 2016-01-22, under approval number K152497.

What company makes PW Guidewires?

PW Guidewires is manufactured by Tatara Vascular, LLC.

What is the FDA product code for PW Guidewires?

The FDA product code for PW Guidewires 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.

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