# K062425: Lifecath S Picc and Midline Catheter

- Pathway: 510(k) (Special)
- Applicant: Vygon Corp.
- Decided: Sep 15, 2006 after 28 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903648 (1991). 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)
- K030270: 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon, Medcomp (2003) Summary page 1.
- K903648: Vygon Lifevac Picc, Vygon Corp. (1991) Summary page 1.
- K983544: Vygon Double Lumen Picc-Catheters (4FR. and 5FR.), Vygon Corp. (1999) Summary page 1.
- K993442: Vygon Lifecath-Picc (Pur) Catheters (Single and Double Lumen 3FR, 4FR, 4.5FR, and 5FR), Vygon Corp. (2000) Summary page 1.

## Recalls of this device
- Apr 26, 2011 · Not classified · Z-2699-2011: Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
- Apr 26, 2011 · Not classified · Z-2700-2011: Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

## Indications for use
The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.

Source page: https://510kreport.com/device/K062425
Methodology: https://510kreport.com/methodology