FDA 510(k) Applications Submitted by Daniel R. Plonski

FDA 510(k) Number Submission Date Device Name Applicant
K153156 11/02/2015 eCareManager 4.0.1 VISICU, INC.
K111606 06/09/2011 PINNACLE PRECISION ACCESS SYSTEM TERUMO MEDICAL CORP.
K102008 07/16/2010 GLIDESHEATH TERUMO MEDICAL CORP.
K062215 08/01/2006 CONFIDANT 2.0 CONFIDANT INC.
K112382 08/18/2011 TERUMO ASPRIATION CATHETER Terumo Medical Corporation
K072698 09/24/2007 CONFIDANT 2.5 CONFIDANT INC.
K122980 09/26/2012 GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ Terumo Medical Corporation
K083331 11/12/2008 CONFIDANT, MODEL 2.6 CONFIDANT INC.
K180571 03/05/2018 GammaPod Xcision Medical Systems, LLC
K171029 04/06/2017 eCareCoordinator Visicu Inc.
K171322 05/05/2017 eCareManager 4.1 Visicu, Inc.
K172706 09/07/2017 GammaPod - Model A Xcision Medical Systems, LLC


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