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FDA 510(k), K181446, Bard Power-Injectable Implantable Ports (PowerPorts®)
FDA 510(k), K181446, Bard Power-Injectable Implantable Ports (PowerPorts®)
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510(K) Number: K181446
Device Name: Bard Power-Injectable Implantable Ports (PowerPorts®)
Manufacturer: C.R. Bard, Inc.
Device Classification Name: port & catheter, implanted, subcutaneous, intravascular
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 06/01/2018
Decision Date: 07/08/2019
Regulation Medical Specialty: General Hospital
Device Name: Bard Power-Injectable Implantable Ports (PowerPorts®)
Manufacturer: C.R. Bard, Inc.
Device Classification Name: port & catheter, implanted, subcutaneous, intravascular
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 06/01/2018
Decision Date: 07/08/2019
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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