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

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

510(k) Number

K073093 ↗

FDA Product Code

MSD

Models / Variants

DEC19SH24

DEC23SH28

DEC23SH32

DEC31SH36

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

• 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

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

  Class II

  FDA 510(k) K040509 Active Cleared 19 Apr 2004

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