# K961580: Port-a-Cath P.a.S. Port II Implantable Venous Access Sytems

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Sep 20, 1996 after 149 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.
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. The FDA summary names its predicate without a number.
- (no number) PORT-A-CATH® P.A.S. PORT® Implantable Venous Access Systems: named in the summary without a submission number
- (no number) PeriPort™ Peripheral Access System: named in the summary without a submission number

## Indications for use
Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K961580
Methodology: https://510kreport.com/methodology