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 with Filter

K-Number: K233284 · 2024-05-01

ApplicantHangzhou Qiantang Longyue Biotechnology Co., Ltd.
Decision Date2024-05-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial Adapter with Filter is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K233284. 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 with Filter?

Vial Adapter with Filter is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. The 510(k) number is K233284.

When did Vial Adapter with Filter receive FDA 510(k) clearance?

Vial Adapter with Filter received FDA 510(k) clearance on 2024-05-01, under 510(k) number K233284.

Who is the listed applicant for Vial Adapter with Filter?

The FDA 510(k) record lists Hangzhou Qiantang Longyue Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter with Filter?

The FDA product code for Vial Adapter with Filter is LHI.

Other records listing Hangzhou Qiantang Longyue Biotechnology 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.

K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)K260301Vial AdapterK233287Vent Vial AdapterK233277Filter Needle for Single UseK222718Vial Adapter

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.

↑