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FDA 510(k)

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire

K-Number: K152231 · 2016-02-12

ApplicantBoston Scientific Corporation
Decision Date2016-02-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-02-12 under approval number K152231. 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 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Boston Scientific Corporation. The 510(k) number is K152231.

When was Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire approved by the FDA?

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire received FDA 510(k) clearance on 2016-02-12, under approval number K152231.

What company makes Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is manufactured by Boston Scientific Corporation.

What is the FDA product code for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

The FDA product code for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire 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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