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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device flowmeter, blood, cardiovascular
Regulation Description Cardiovascular blood flowmeter.
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DELTEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
EMTECH GMBH
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOSTRA
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOPROBE CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
OR-NIM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROSSMAX INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR CONTROL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 6
Device operates differently than expected 1
No Information 1
Noise, Audible 1
Failure to run on AC/DC 1
Burn of device or device component 1
Electrical issue 1
Fire 1
Occlusion within device 1
Pre or post-pumping problem 1
Pumping stopped 1
Inadequate service 1
Improper or incorrect procedure or method 1
Total Device Problems 18

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 1 0 2 1 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II May-10-2016
2 Baxter Healthcare Corporation II Jul-29-2014
3 Escalon Medical Corp II Oct-22-2010
4 Parks Medical Electronics Inc III Jul-03-2008
5 Parks Medical Electronics, Inc II Dec-10-2012
6 Transonic Systems Inc II Sep-03-2015
7 Vascular Technology, Inc. II Jul-07-2014

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