CADD Yellow High Volume Administration Set with NRFit connector— 510(k) K172592
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K172592 for CADD Yellow High Volume Administration Set with NRFit connector, Substantially Equivalent on 2018-05-17. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code PWH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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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.