Cleared Traditional

Vial Adapter with Filter

K233284 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · General Hospital
May 2024
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K233284 is an FDA 510(k) clearance for the Vial Adapter with Filter, 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 May 1, 2024, 215 days after receiving the submission on September 29, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K233284 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date May 01, 2024
Days to Decision 215 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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