Split Cath Iii 24cm Split Cath Iii 24cm Split Cath Iii 32cm Cath Iii 36cm Split Cath Iii 40cm and 55cm

• • Terminated Z-2592-2014 FDA Class II ·initiated 4 Aug 2014

  The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

510(k) Number

K121848 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

Manufacturer's product page: Split Cath®

• Duo Flow Catheter-Mc 54

  Class II

  FDA 510(k) K842416 Active Cleared 26 Jul 1984

• MCSCP8PS with 'y' Hub

  Class II

  FDA 510(k) K821684 Active Cleared 24 Jun 1982

• Twin Silicone Catheter

  Class II

  FDA 510(k) K923691 Active Cleared 25 Sep 1995

• Medicomp Flexi-Smooth Wound Drainage Catheter

  Class I

  FDA 510(k) K960426 Active Cleared 21 Mar 1996

• 1.9F X 20cm Vascu-Picc 1.9F X 50cm Vascu-Picc

  Class II

  FDA 510(k) K120980 Active Cleared 2 May 2012

• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

See all devices from Medical Components, Inc. →