Aortic Root Cannula W/Integral Press

• 2 recalls, same reason

  • Terminated Z-2766-2017 FDA Class II ·initiated 22 Jun 2017
  • Terminated Z-2767-2017 FDA Class II ·initiated 22 Jun 2017

  Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

510(k) Number

K831591 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infant Vent Catheter 12001 W/Side Vent Open recall

  Class II

  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

  Class II

  FDA 510(k) K821149 Active Cleared 18 May 1982

• Percutaneous Guidewire Placement Syringe 50505

  Class II

  FDA 510(k) K855089 Active Cleared 18 Feb 1986

• Clearview Blower/Mister Open recall

  Class II

  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

  Class II

  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Code #94315 Retrograde Coronary Sinus Perf Cannula

  Class II

  FDA 510(k) K901074 Active Cleared 6 Jul 1990

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