# K073093: Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Jan 22, 2008 after 82 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
Longest line of descent: 2 generations back to K925626 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips, Spire Biomedical, Inc. (2006) Summary page 1.

## Indications for use
Spire Biomedical, Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K073093
Methodology: https://510kreport.com/methodology