# K010306: Medcomp Excell Split Tip Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Oct 3, 2001 after 244 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.
13 later devices descend from it; 2 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040992: 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706 (2004), 8 descendants of its own
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (2007), 7 descendants of its own
- K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit (2008), 6 descendants of its own
- K113487: Hemo-Cath 10F, Hemo-Cath 12.5F (2012), 3 descendants of its own
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit (2010), 2 descendants of its own

Source page: https://510kreport.com/device/K010306
Methodology: https://510kreport.com/methodology