24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter With Separated Tips

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K021212 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, De 31/36SH, DE19/24NH

  Class II

  FDA 510(k) K032061 Active Cleared 23 Dec 2003

• Retro Repair Kit, Model PRRK5

  Class II

  FDA 510(k) K022644 Active Cleared 6 Nov 2002

• Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

  Class II

  FDA 510(k) K073093 Active Cleared 22 Jan 2008

• 15.5Fr Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55

  Class II

  FDA 510(k) K063441 Active Cleared 12 Feb 2007

• 55cm Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55, RS50NH55, RE50SH55 & RE50NH55

  Class II

  FDA 510(k) K041559 Active Cleared 30 Jul 2004

• Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt

  Class II

  FDA 510(k) K022620 Active Cleared 11 Oct 2002

See all devices from Spire Biomedical, Inc. →

• What is the primary purpose of the twin-lumen design in this hemodialysis catheter, and how does it benefit patients during dialysis sessions?

  The twin-lumen design with separated tips in the 24CM POURCHEZ XPRESSO Chronic Hemodialysis Catheter is engineered to optimize blood flow efficiency during hemodialysis. This configuration allows simultaneous blood withdrawal and return, reducing turbulence and improving overall dialysis performance. The separated tips help minimize clotting and enhance the catheter’s reliability for long-term use in patients requiring repeated hemodialysis sessions.

• Is this catheter intended for single-use or can it be reused for multiple chronic hemodialysis sessions?

  The 24CM POURCHEZ XPRESSO Twin Lumen Chronic Hemodialysis Catheter is supplied sterile and explicitly intended for single-use implantation. However, once implanted, it is designed for chronic hemodialysis sessions, meaning it can remain in place for extended periods to support ongoing dialysis treatment. Reuse beyond the manufacturer’s intended use should follow strict clinical guidelines to ensure safety and efficacy.

• What are the key storage considerations for this catheter before implantation, given the lack of specified storage conditions in the regulatory data?

  While the regulatory data does not detail storage conditions, standard practices for sterile, implanted medical devices like this catheter typically require storage in a clean, dry environment protected from contamination. It should be kept in its original, sealed packaging until ready for use to maintain sterility. If specific storage instructions (e.g., temperature or humidity constraints) are provided in the manufacturer’s labeling or accompanying documentation, those should be followed to preserve device integrity.

• What medical specialties are most commonly associated with the use of this catheter, and why?

  This catheter is primarily associated with gastroenterology and urology specialties, as indicated by its FDA 510(k) clearance under Special Review for these fields. While its core indication is for chronic hemodialysis access, its design and regulatory classification align with procedures involving central venous access—common in both specialties. Clinicians in these areas may rely on it for patients requiring long-term vascular access, particularly those with renal failure undergoing dialysis.

• How does the length of this catheter (24 cm) influence its placement and suitability for patients?

  The 24 cm length of the POURCHEZ XPRESSO Twin Lumen Catheter is optimized for insertion into central veins such as the internal jugular vein, a common site for hemodialysis catheters. This length balances reach and maneuverability, allowing for stable placement while minimizing risks like venous perforation or improper positioning. The design ensures the catheter can be advanced far enough to secure reliable blood flow for dialysis while remaining accessible for maintenance or removal.