14F X 24cm Ash Split-Cath, 14F X 28cm Ash Split-Cath, 14F X 32cm Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40cm Ash

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013162 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Raulerson One-Step Guidewire Insertion Bulb Needle

  Class II

  FDA 510(k) K971281 Active Cleared 9 Oct 1997

• Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)

  Class II

  FDA 510(k) K081904 Active Cleared 23 Sep 2008

• Medcomp Ash Split-Cath 28cm, Medcomp Ash Split-Cath 32cm

  Class II

  FDA 510(k) K972207 Active Cleared 23 Feb 1998

• Split Cath Rg

  Class II

  FDA 510(k) K130889 Active Cleared 28 Apr 2014

• Medcomp Split-Cath II

  Class II

  FDA 510(k) K040318 Active Cleared 3 Feb 2005

• Medcomp Split Cath II

  Class II

  FDA 510(k) K051280 Active Cleared 30 Nov 2005

See all devices from Medcomp →

• What is the 14F ASH Split-Cath used for?

  This device is designed for long-term hemodialysis and apheresis procedures. Its double-lumen design with segregated D-shaped lumens and extended distal venous lumen helps minimize recirculation during treatment, supporting efficient blood flow access.

• How is the 14F ASH Split-Cath supplied and what sizes are available?

  The catheter is supplied in the specific lengths listed in the product name: 24cm, 28cm, 32cm, 36cm, and 40cm, all with a 14 French diameter. It is intended for percutaneous insertion, primarily in the internal jugular vein, with alternate sites including subclavian and inferior vena cava.

• Is the 14F ASH Split-Cath sterile and intended for single use?

  While the provided data does not explicitly state sterility or single-use status, the device is designed for percutaneous insertion and long-term hemodialysis access, which implies it is supplied sterile for single-patient use. Reuse would require appropriate reprocessing, but the data does not confirm reuse validation.

• What regulatory pathway authorized the 14F ASH Split-Cath?

  The device is authorized under FDA 510(k) clearance K013162, as indicated in the AUTHORIZATIONS and k_number fields. This means it was found substantially equivalent to a legally marketed predicate device.

• Where should the 14F ASH Split-Cath be stored before use?

  The device data does not include specific storage conditions. However, as a polyurethane catheter intended for vascular access, it should be stored in a cool, dry place away from direct sunlight and extreme temperatures, following standard medical device storage practices unless otherwise labeled.