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FDA 510(k)

Disposable IV catheter

K-Number: K202060 · 2021-07-23

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2021-07-23
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable IV catheter is a medical device manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under approval number K202060. 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 Disposable IV catheter?

Disposable IV catheter is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K202060.

When was Disposable IV catheter approved by the FDA?

Disposable IV catheter received FDA 510(k) clearance on 2021-07-23, under approval number K202060.

What company makes Disposable IV catheter?

Disposable IV catheter is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd..

What is the FDA product code for Disposable IV catheter?

The FDA product code for Disposable IV catheter is FOZ.

Related Clinical Trials

NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Shinva Ande Healthcare Apparatus Co., Ltd.

K162601Infusion Set for Single Use K193657Disposable Enteral Feeding Syringe with Enfit Connector K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

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

View on FDA Database →

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

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