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)

Vial Adapter 15mm

K-Number: K171796 · 2017-10-12

ApplicantMedimop Medical Project , Ltd.
Decision Date2017-10-12
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial Adapter 15mm 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 2017-10-12 under 510(k) number K171796. 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 Vial Adapter 15mm?

Vial Adapter 15mm is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Medimop Medical Project , Ltd.. The 510(k) number is K171796.

When did Vial Adapter 15mm receive FDA 510(k) clearance?

Vial Adapter 15mm received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171796.

Who is the listed applicant for Vial Adapter 15mm?

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 Vial Adapter 15mm?

The FDA product code for Vial Adapter 15mm 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.

K170095Vial2Bag Direct Connect

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.

↑