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FDA 510(k)

EasyPass Guidewire

K-Number: K153264 · 2016-05-19

ApplicantMedi-Globe Corporation
Decision Date2016-05-19
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EasyPass Guidewire is a medical device manufactured by Medi-Globe Corporation. It received FDA 510(k) clearance on 2016-05-19 under approval number K153264. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyPass Guidewire?

EasyPass Guidewire is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Medi-Globe Corporation. The 510(k) number is K153264.

When was EasyPass Guidewire approved by the FDA?

EasyPass Guidewire received FDA 510(k) clearance on 2016-05-19, under approval number K153264.

What company makes EasyPass Guidewire?

EasyPass Guidewire is manufactured by Medi-Globe Corporation.

What is the FDA product code for EasyPass Guidewire?

The FDA product code for EasyPass Guidewire is OCY.

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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