Closed System Transfer Device— 510(k) K201460
Substantially EquivalentShinva Ande Healthcare Apparatus Co., Ltd.
FDA 510(k) clearance K201460 for Closed System Transfer Device, Substantially Equivalent on 2022-11-23. Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shinva Ande Healthcare Apparatus Co., Ltd.
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zibo, CN
Recent devices under product code ONB
view all- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
- K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K251411 — Chemfort Female Luer Lock Adaptor
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
More clearances from Shinva Ande Healthcare Apparatus Co., Ltd.
view all- K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
- K211484 — Disposable Sterile Syringe with Safety Needle +3 more
- K202060 — Disposable IV catheter
- K193657 — Disposable Enteral Feeding Syringe with Enfit Connector
- K162601 — Infusion Set for Single Use
Adverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
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.