# K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips

- Pathway: 510(k) (Special)
- Applicant: Spire Biomedical, Inc.
- Decided: May 17, 2002 after 30 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: 1 generation back to K013160 (2002). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter, Spire Biomedical, Inc. (2002) Summary page 2.
- (no number) Medical Components, Inc. Ash Split Cath™: named in the summary without a submission number

## Most influential descendants
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) (2002), 9 descendants of its own
- K043292: Hemocath (2005), 3 descendants of its own
- K062901: Hemocath II (2007), 2 descendants of its own
- K071202: Dermaport Percutaneous Vascular Access System (Pvas) (2007), 1 descendant of its own
- K041559: 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (2004), 1 descendant of its own

## Indications for use
The Pourchez XpressO™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

Source page: https://510kreport.com/device/K021212
Methodology: https://510kreport.com/methodology