Strato/Infusaid Life & Infuse-a-Port Implantable Port System

• • Terminated Z-0256-05 FDA Unclassified (pre-2012) ·initiated 20 Sep 2004

  The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.

510(k) Number

K953529 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Strato/Infusaind Microport Vascular Acc. System

  Class II

  FDA 510(k) K951873 Active Cleared 19 May 1995

• Strato/Infusaid Dualport Vascular Acc. System

  Class II

  FDA 510(k) K951872 Active Cleared 18 May 1995

• Strato/Infusaid Infuse-a-Cath Single Lumen Silicone Central Venous Catheter Systesm

  Class II

  FDA 510(k) K953436 Active Cleared 4 Oct 1995

• Strato/Infusaif Infuse-a-Cath Central Venous Catheters

  Class II

  FDA 510(k) K954720 Active Cleared 4 Jan 1996

• Strato/Infusaid Periport Infusion Set 41770, 41771

  Class II

  FDA 510(k) K960391 Active Cleared 3 Jul 1996

• Strato/Infusaid Infus-a-Cath Dual Lumen Preattached Silicone Central Venous Catheter Systems

  Class II

  FDA 510(k) K953256 Active Cleared 4 Oct 1995

See all devices from Strato/Infusaid, Inc. →