Disposable IV catheter— 510(k) K202060
Substantially EquivalentShinva Ande Healthcare Apparatus Co., Ltd.
FDA 510(k) clearance K202060 for Disposable IV catheter, Substantially Equivalent on 2021-07-23. Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shinva Ande Healthcare Apparatus Co., Ltd.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zibo, CN
Recent devices under product code FOZ
view allMore clearances from Shinva Ande Healthcare Apparatus Co., Ltd.
view all- K201460 — Closed System Transfer Device
- K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
- K211484 — Disposable Sterile Syringe with Safety Needle +3 more
- K193657 — Disposable Enteral Feeding Syringe with Enfit Connector
- K162601 — Infusion Set for Single Use
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.