Truflow Dual-Lumen Polyurethane Long-Term Straight Dialysis Catheter (12.5 Fr X 24 Cm) with Tray, Truflow Dual-Lumen Poy

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K030983 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• Cadd High-Volume Administration Sets with Flowstop Open recall

  Class II

  FDA 510(k) K031361 Active Cleared 23 May 2003

• Gripper Plus Needle

  Class II

  FDA 510(k) K021999 Active Cleared 13 Aug 2002

• Deltec Insulin Infusion Pump and Accessories

  Class II

  FDA 510(k) K020655 Active Cleared 13 Aug 2002

• Truflow Long-Term and Short-Term Dual-Lumen Dialysis Catheters

  Class II

  FDA 510(k) K022221 Active Cleared 30 Jan 2003