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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 the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) 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. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K202060.

When did Disposable IV catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable IV catheter?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable IV catheter?

The FDA product code for Disposable IV catheter is FOZ.

Other records listing Shinva Ande Healthcare Apparatus 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.

K201460Closed System Transfer DeviceK220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose ImmunizationK211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety NeedlesK193657Disposable Enteral Feeding Syringe with Enfit ConnectorK162601Infusion Set for Single Use

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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