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FDA 510(k)

SUPERCATH 5 (26G)

K-Number: K172496 · 2018-03-23

ApplicantTogo Medikit Co., Ltd.
Decision Date2018-03-23
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUPERCATH 5 (26G) 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 2018-03-23 under 510(k) number K172496. 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 (26G)?

SUPERCATH 5 (26G) is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K172496.

When did SUPERCATH 5 (26G) receive FDA 510(k) clearance?

SUPERCATH 5 (26G) received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172496.

Who is the listed applicant for SUPERCATH 5 (26G)?

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 (26G)?

The FDA product code for SUPERCATH 5 (26G) 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 SheathK190001Supercath 5K160592SUPERCATH 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.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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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