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FDA 510(k), K153359, BardPort®, SlimPort®, and X-Port® Implanted Ports
FDA 510(k), K153359, BardPort®, SlimPort®, and X-Port® Implanted Ports
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510(K) Number: K153359
Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports
Manufacturer: JAMES R. DAVIS
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation Number: LJT
Classification Product Code: 11/20/2015
Date Received: 05/20/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports
Manufacturer: JAMES R. DAVIS
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation Number: LJT
Classification Product Code: 11/20/2015
Date Received: 05/20/2016
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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