Strato Port Introducer Kt (10 Fr) Lps 5057/MODIFIED

• • Terminated Z-0405-2011 FDA Unclassified (pre-2012) ·initiated 27 Sep 2010 ·on shared 510(k) K905840

  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

K905840 ↗

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. →

• What is the primary function of the Strato Port Introducer Kt?

  This device is an implanted, subcutaneous, intravascular port and catheter system designed to facilitate vascular access for various medical procedures.

• What is the regulatory classification of this device?

  The Strato Port Introducer Kt is classified as a Class II medical device and has received FDA 510(k) clearance under K905840.

• What are the physical specifications of this specific model?

  This device is identified as the 10 Fr LPS 5057/Modified model, manufactured by Strato Medical Corp. and regulated under product code LJT.