# K070911: STD Med Primo Port

- Pathway: 510(k) (Abbreviated)
- Applicant: Std Med, Inc.
- Decided: Aug 10, 2007 after 130 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 K870260 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050310: Bardport Titanium Ports, Bard Access Systems, Inc. (2005) Summary page 1.

## Indications for use
The STD Med Primo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Source page: https://510kreport.com/device/K070911
Methodology: https://510kreport.com/methodology