Strato Port Introducer Kt(10 Fr) Lps 5013/Modified

• • Terminated Z-0405-2011 FDA Unclassified (pre-2012) ·initiated 27 Sep 2010 ·on shared 510(k) K905839

  Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

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

510(k) Number

K905839 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Strato Plast W/Pre-Attach Cath(Lps 6015)/Modified

  Class II

  FDA 510(k) K905851 Active Cleared 5 Apr 1991

• Lifeport Attachable System W/Inducer Kit Lps 5555

  Class II

  FDA 510(k) K915273 Active Cleared 7 Jul 1993

• Stratofuse Syringe Piggyback Pump 1030

  Class II

  FDA 510(k) K850488 Active Cleared 21 Mar 1985

• Strato Life Port II Dual Lumen Port/Modification

  Class II

  FDA 510(k) K905847 Active Cleared 5 Apr 1991

• Infuse-A-Cath Silicone Central Venous Catheter

  Class II

  FDA 510(k) K921751 Active Cleared 7 Jul 1993

• Life-Port Implantable Vascular Access

  Class II

  FDA 510(k) K853827 Active Cleared 13 Nov 1986

See all devices from Strato Medical Corp. →