FDA 510(k), K162219, CADD® Infusion Disposables Portfolio with NRFit™ connectors
FDA 510(k), K162219, CADD® Infusion Disposables Portfolio with NRFit™ connectors
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510(K) Number: K162219
Device Name: CADD® Infusion Disposables Portfolio with NRFit™ connectors
Manufacturer: Wendy J. Kivens
Device Classification Name: Administrations Sets With Neuraxial Connectors
Regulation Number: PWH
Classification Product Code: 08/08/2016
Date Received: 07/20/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: CADD® Infusion Disposables Portfolio with NRFit™ connectors
Manufacturer: Wendy J. Kivens
Device Classification Name: Administrations Sets With Neuraxial Connectors
Regulation Number: PWH
Classification Product Code: 08/08/2016
Date Received: 07/20/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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