Medcomp Tesio Catheter, Models Mbr-6, Mbl-6, Mbs-6

• • Terminated Z-1121-2018 FDA Class II ·initiated 23 Feb 2018 ·via K981125, on the same 510(k)

  There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K981125 ↗

FDA Product Code

MSD

Models / Variants

Mbr-6

Mbl-6

Mbs-6

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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