14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets Accessory

• 4 recalls, same reason

  • Terminated Z-0409-2009 FDA Unclassified (pre-2012) ·initiated 19 Sep 2008 ·on shared 510(k) K051584
  • Terminated Z-0411-2009 FDA Unclassified (pre-2012) ·initiated 19 Sep 2008 ·on shared 510(k) K051584
  • Terminated Z-0408-2009 FDA Unclassified (pre-2012) ·initiated 19 Sep 2008 ·on shared 510(k) K051584
  • Terminated Z-0410-2009 FDA Unclassified (pre-2012) ·initiated 19 Sep 2008 ·on shared 510(k) K051584

  Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K051584 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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