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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 the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corporation. It received FDA 510(k) clearance on 2016-05-19 under 510(k) 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. The listed applicant is Medi-Globe Corporation. The 510(k) number is K153264.

When did EasyPass Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for EasyPass Guidewire?

The FDA 510(k) record lists Medi-Globe Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyPass Guidewire?

The FDA product code for EasyPass Guidewire is OCY.

Other records listing Medi-Globe Corporation 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.

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Official Source

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