# K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes)

- Pathway: 510(k) (Special)
- Applicant: Spire Biomedical, Inc.
- Decided: Jul 19, 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: 2 generations back to K013160 (2002). 3 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 13 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)
- K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips, Spire Biomedical, Inc. (2002) Summary page 1.
- K002902: Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers, The Kendall Company (2001) Summary page 1.

## Most influential descendants
- 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
- K022644: Retro Repair Kit, Model PRRK5 (2002), 1 descendant of its own

## Indications for use
Spire Biomedical, Inc.'s Pourchez RetrOTMSilicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque silicone catheter designed for percutaneous insertion or insertion via a cutdown.

Source page: https://510kreport.com/device/K022000
Methodology: https://510kreport.com/methodology