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)

Closed System Transfer Device

K-Number: K201460 · 2022-11-23

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2022-11-23
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Closed System Transfer Device 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 2022-11-23 under 510(k) number K201460. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Closed System Transfer Device?

Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K201460.

When did Closed System Transfer Device receive FDA 510(k) clearance?

Closed System Transfer Device received FDA 510(k) clearance on 2022-11-23, under 510(k) number K201460.

Who is the listed applicant for Closed System Transfer Device?

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 Closed System Transfer Device?

The FDA product code for Closed System Transfer Device is ONB.

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.

K220057Disposable 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 NeedlesK202060Disposable IV catheterK193657Disposable Enteral Feeding Syringe with Enfit ConnectorK162601Infusion Set for Single Use

Related Devices (Code: ONB)

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.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , 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.

↑