# K101017: Angiodynamics, Inc., Smart Port CT Series Port Access Systems

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Jun 17, 2010 after 66 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190559: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (2020), 0 descendants of its own

## Indications for use
The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Source page: https://510kreport.com/device/K101017
Methodology: https://510kreport.com/methodology