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)

Vial2Bag Direct Connect

K-Number: K170095 · 2017-03-08

ApplicantMedimop Medical Project , Ltd.
Decision Date2017-03-08
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial2Bag Direct Connect is the device name listed in this FDA 510(k) record. The listed applicant is Medimop Medical Project , Ltd.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K170095. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vial2Bag Direct Connect?

Vial2Bag Direct Connect is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Medimop Medical Project , Ltd.. The 510(k) number is K170095.

When did Vial2Bag Direct Connect receive FDA 510(k) clearance?

Vial2Bag Direct Connect received FDA 510(k) clearance on 2017-03-08, under 510(k) number K170095.

Who is the listed applicant for Vial2Bag Direct Connect?

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

What is the FDA product code for Vial2Bag Direct Connect?

The FDA product code for Vial2Bag Direct Connect is LHI.

Other records listing Medimop Medical Project , 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.

K171796Vial Adapter 15mm

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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.

↑