# K041468: Premicath, 1261.205

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Sep 9, 2004 after 99 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: 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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 27, 2005 · Not classified · Z-0090-06: Guidewire protuding from tip of the catheter

## Indications for use
Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization. The catheter is used for mid- to long-term infusion of TPN or intravenous medications.

Source page: https://510kreport.com/device/K041468
Methodology: https://510kreport.com/methodology