# K033686: Port-a-Cath II Regional Arterial Portal System

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Jan 23, 2004 after 60 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: 2 generations back to K830730 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992697: Port-a-Cath II Trans-Arterial Percutaneous System, Sims Deltec, Inc. (1999) Summary page 2.
- K932840: Port-a-Cath Implantable Vascular Access System, Pharmacia Deltec, Inc. (1994) Summary page 2.

## Indications for use
The PORT-A-CATH ® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.

Source page: https://510kreport.com/device/K033686
Methodology: https://510kreport.com/methodology