# K955407: Port-a-Cath Dual Lumen Implantable Venous

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Feb 12, 1996 after 77 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 10, 2013 · Class II · Z-2269-2013: Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small numbe

Source page: https://510kreport.com/device/K955407
Methodology: https://510kreport.com/methodology