# K040492: Vaxcel Plus Chronic Dialysis Catheter Tunneler

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 16, 2004 after 19 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- 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 no predicate by number.

## Indications for use
The Vaxce]Tm Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling and insertion of VaxcelTM Plus Chronic Dialysis Catheters of correspondng size (19, 23, 28 cm).

Source page: https://510kreport.com/device/K040492
Methodology: https://510kreport.com/methodology