Triactiv System

• 3 recalls, same reason

  • Terminated Z-1221-06 FDA Unclassified (pre-2012) ·initiated 24 May 2006
  • Terminated Z-1220-06 FDA Unclassified (pre-2012) ·initiated 24 May 2006
  • Terminated Z-1219-06 FDA Unclassified (pre-2012) ·initiated 24 May 2006

  volume control knob not able to go up to larger diameters

510(k) Number

K042040 ↗

FDA Product Code

NFA

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Kensey Nash Wuik-Sert(Tm) Endoscopic Surg Grasper

  Class II

  FDA 510(k) K926089 Active Cleared 23 Jul 1993

• Meso Wound Matrix

  Unclassified

  FDA 510(k) K112888 Active Cleared 10 Feb 2012

• Quickcat Extraction Catheter, Model 60090-01

  Class II

  FDA 510(k) K073519 Active Cleared 28 Mar 2008

• Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XX

  Class II

  FDA 510(k) K091192 Active Cleared 2 Nov 2009

• Thromcat Thrombectomy Catheter System

  Class II

  FDA 510(k) K072195 Active Cleared 23 Aug 2007

• Medeor Matrix, Models 30010-Xx (Hydrated); 30020-Xx (Dry)

  Class II

  FDA 510(k) K091499 Active Cleared 22 Oct 2009

See all devices from Kensey Nash Corp. →