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FDA 510(k), K161777, BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
FDA 510(k), K161777, BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
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510(K) Number: K161777
Device Name: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Manufacturer: Kimberly Geisler
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: 06/29/2016
Date Received: 08/29/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Manufacturer: Kimberly Geisler
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: 06/29/2016
Date Received: 08/29/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- 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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