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FDA 510(k)

SUPERCATH Z3V

K-Number: K112290 · 2012-04-16

ApplicantTogo Medikit Co., Ltd.
Decision Date2012-04-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUPERCATH Z3V is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2012-04-16 under 510(k) number K112290. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERCATH Z3V?

SUPERCATH Z3V is a medical device that received FDA 510(k) clearance on 2012-04-16. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K112290.

When did SUPERCATH Z3V receive FDA 510(k) clearance?

SUPERCATH Z3V received FDA 510(k) clearance on 2012-04-16, under 510(k) number K112290.

Who is the listed applicant for SUPERCATH Z3V?

The FDA 510(k) record lists Togo Medikit Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPERCATH Z3V?

The FDA product code for SUPERCATH Z3V is FOZ.

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Other records listing Togo Medikit Co., Ltd. as applicant

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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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