Intracardiac Sump 12010

• • Ongoing Z-1797-2024 FDA Class II ·initiated 19 Mar 2024

  Potential for unsealed sterile packing.

• • Terminated Z-0609-2009 FDA Unclassified (pre-2012) ·initiated 29 Sep 2008

  Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.

510(k) Number

K850385 ↗

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

• Aortic Root Cannula W/Integral Press

  Class II

  FDA 510(k) K831591 Active Cleared 30 Jun 1983

See all devices from Dlp, Inc. →