FDA 510(k)

Supercath 5

K-Number: K190001 · 2019-09-20

Decision Date2019-09-20

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Supercath 5 is a medical device manufactured by Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2019-09-20 under approval 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. It is manufactured by Togo Medikit Co., Ltd.. The 510(k) number is K190001.

When was Supercath 5 approved by the FDA?

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

What company makes Supercath 5?

Supercath 5 is manufactured by Togo Medikit Co., Ltd..

What is the FDA product code for Supercath 5?

The FDA product code for Supercath 5 is FOZ.

Other Devices by Togo Medikit Co., Ltd.

K160592SUPERCATH 6 K172496SUPERCATH 5 (26G) K200379Super Sheath K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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.