Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX

K-Number: K093546 · 2009-12-17

ApplicantTogo Medikit Co., Ltd.
Decision Date2009-12-17
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX 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 2009-12-17 under 510(k) number K093546. 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 MODEL SP120-XX-XX, SP125-XX-XX?

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX is a medical device that received FDA 510(k) clearance on 2009-12-17. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K093546.

When did SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX receive FDA 510(k) clearance?

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX received FDA 510(k) clearance on 2009-12-17, under 510(k) number K093546.

Who is the listed applicant for SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX?

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 MODEL SP120-XX-XX, SP125-XX-XX?

The FDA product code for SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX is FOZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 5K172496SUPERCATH 5 (26G)K160592SUPERCATH 6K121504SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS

View all 15 devices →

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.

K260432Ruby Intravascular CatheterVenocare, Inc.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.

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.

↑