# K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Apr 11, 2002 after 202 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.
16 later devices descend from it; 5 cite it directly.
0 of 17 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 its predicate without a number.
- (no number) Medical Components, Inc. Ash Split Cath™: named in the summary without a submission number
- (no number) Quinton Instruments Company, Adult Perm-Cath™: named in the summary without a submission number

## Most influential descendants
- K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (2002), 10 descendants of its own
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) (2002), 9 descendants of its own
- K032061: Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (2003), 4 descendants of its own
- K043292: Hemocath (2005), 3 descendants of its own
- K062901: Hemocath II (2007), 2 descendants 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/K013160
Methodology: https://510kreport.com/methodology