# K012365: Vaxcel Dialysis Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 24, 2001 after 29 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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 no predicate by number.

## Most influential descendants
- K023847: Hemo-Stream Hemodialysis Catheter Set (2003), 6 descendants of its own
- K071422: 15.5F Hemo-Stream Hemodialysis Catheter Set (2007), 5 descendants of its own
- K102043: Ultrastream Chronic Hemodialysis Catheter (2010), 4 descendants of its own
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own

## Indications for use
The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

Source page: https://510kreport.com/device/K012365
Methodology: https://510kreport.com/methodology