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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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