Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use— 510(k) K181870
Substantially EquivalentWuhan W.E.O Science & Technology Development Co., Ltd.
FDA 510(k) clearance K181870 for Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use, Substantially Equivalent on 2019-02-26. Applicant: Wuhan W.E.O Science & Technology Development Co., Ltd..
Clearance details
- Applicant
- Wuhan W.E.O Science & Technology Development Co., Ltd.
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhun, CN
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.