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FDA 510(k)

Supercath 5

K-Number: K190001 · 2019-09-20

ApplicantTogo Medikit Co., Ltd.
Decision Date2019-09-20
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Supercath 5 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 2019-09-20 under 510(k) number K190001. 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 5?

Supercath 5 is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K190001.

When did Supercath 5 receive FDA 510(k) clearance?

Supercath 5 received FDA 510(k) clearance on 2019-09-20, under 510(k) number K190001.

Who is the listed applicant for Supercath 5?

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 5?

The FDA product code for Supercath 5 is FOZ.

Other records listing Togo Medikit Co., Ltd. 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.

K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008K200379Super SheathK172496SUPERCATH 5 (26G)K160592SUPERCATH 6

Related Devices (Code: FOZ)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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