FDA 510(k)

OSTAVI HYDROPHILIC GUIDEWIRE

K-Number: K124052 · 2013-02-26

Decision Date2013-02-26

Product CodeOCY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OSTAVI HYDROPHILIC GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2013-02-26 under 510(k) number K124052. 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 OSTAVI HYDROPHILIC GUIDEWIRE?

OSTAVI HYDROPHILIC GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2013-02-26. The listed applicant is Lake Region Medical. The 510(k) number is K124052.

When did OSTAVI HYDROPHILIC GUIDEWIRE receive FDA 510(k) clearance?

OSTAVI HYDROPHILIC GUIDEWIRE received FDA 510(k) clearance on 2013-02-26, under 510(k) number K124052.

Who is the listed applicant for OSTAVI HYDROPHILIC GUIDEWIRE?

The FDA 510(k) record lists Lake Region Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTAVI HYDROPHILIC GUIDEWIRE?

The FDA product code for OSTAVI HYDROPHILIC GUIDEWIRE is OCY.

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Other records listing Lake Region Medical as applicant

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Related Devices (Code: OCY)

K153264EasyPass GuidewireMedi-Globe Corporation K131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/S K123438XENX STONE MANAGEMENT DEVICEXenolith Medical K123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, Inc.K113692XENXXenolith Medical

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.