# K060036: Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: May 17, 2006 after 132 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.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices 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® Implantable Venous Access Systems: named in the summary without a submission number
- (no number) PORT-A-CATH® II Implantable Venous Access Systems: named in the summary without a submission number
- (no number) ProPort® Implantable Venous Access Systems: named in the summary without a submission number
- (no number) P.A.S. PORT® Implantable Venous Access Systems: named in the summary without a submission number

## Most influential descendants
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), 2 descendants of its own

## Indications for use
PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K060036
Methodology: https://510kreport.com/methodology