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

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K022620 ↗

FDA Product Code

FKA

Models / Variants

XRIK24

XRIK28

XRIK32

XRIK36

XRIK40

Xrikrt

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

• Alta Lr Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

  Class II

  FDA 510(k) K040509 Active Cleared 19 Apr 2004

See all devices from Spire Biomedical, Inc. →