FDA 510(k)

MagiCath II

K-Nummer: K210929 · 2022-09-13

AntragstellerWoo Young Medical Co., Ltd.

Entscheidungsdatum2022-09-13

ProduktcodeFOZ

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

MagiCath II is the device name listed in this FDA 510(k) record. The listed applicant is Woo Young Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K210929. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the MagiCath II?

MagiCath II is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Woo Young Medical Co., Ltd.. The 510(k) number is K210929.

When did MagiCath II receive FDA 510(k) clearance?

MagiCath II received FDA 510(k) clearance on 2022-09-13, under 510(k) number K210929.

Who is the listed applicant for MagiCath II?

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

What is the FDA product code for MagiCath II?

The FDA product code for MagiCath II is FOZ.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Verwandte Geräte (Code: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.