# K190559: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: May 22, 2020 after 444 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
Longest line of descent: 12 generations back to K001901 (2000). 69 ancestors in all.
No later device cites it as a predicate yet.
2 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101017: Angiodynamics, Inc., Smart Port CT Series Port Access Systems, AngioDynamics, Inc. (2010) Summary page 4.
- K131694: Nmi Port II Catheter, Navilyst Medical, Inc. (2013) Summary page 5.

## Indications for use
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine. When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle. Needle Size (G), Catheter Size (F) Maximum Recommended Maximum Recommended non-coring power injectable Flow Rate Setting (mL/s) Pressure Setting (psi) 19/20 5,6 and 8 5 300 22 5,6 and 8 2 300

Source page: https://510kreport.com/device/K190559
Methodology: https://510kreport.com/methodology