Cleared Traditional

Vial Adapter

K222718 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · General Hospital
Mar 2023
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K222718 is an FDA 510(k) clearance for the Vial Adapter, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 10, 2023, 183 days after receiving the submission on September 8, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K222718 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2022
Decision Date March 10, 2023
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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