Vial Adapter— 510(k) K222718
Substantially EquivalentHangzhou Qiantang Longyue Biotechnology Co., Ltd.
FDA 510(k) clearance K222718 for Vial Adapter, Substantially Equivalent on 2023-03-10. Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code LHI
view allMore clearances from Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
view all- K260933 — Safety 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)
- K233287 — Vent Vial Adapter
- K233277 — Filter Needle for Single Use
- K233284 — Vial Adapter with Filter
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.