Clampless Valved Catheter - Tunneled (Cvc-T)

• • Terminated Z-1508-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K963806

  The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

• • Terminated Z-1112-05 FDA Unclassified (pre-2012) ·initiated 25 May 2004

  Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.

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

510(k) Number

K963806 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Clampless Valved Catheter - Midline (Cvc-Ml)

  Class II

  FDA 510(k) K963215 Active Cleared 14 Nov 1996

• Clampless Valved Catheter-Picc (Cvc-Picc)

  Class II

  FDA 510(k) K963097 Active Cleared 18 Oct 1996

• Needle-Free Valved Connector and Cap

  Class II

  FDA 510(k) K964439 Active Cleared 16 Jul 1997

• Clampless Valved Catheter

  Class II

  FDA 510(k) K962300 Active Cleared 5 Sep 1996