CADD® Infusion Disposables Portfolio with NRFit connectors— 510(k) K162219
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K162219 for CADD® Infusion Disposables Portfolio with NRFit connectors, Substantially Equivalent on 2017-07-20. Applicant: Smiths Medical Asd, Inc..
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code PWH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code PWH
product code PWH- Other
- 1
- Total
- 1
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.