• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device probe, blood-flow, extravascular
Regulation Description Extravascular blood flow probe.
Product CodeDPT
Regulation Number 870.2120
Device Class 2


Premarket Reviews
ManufacturerDecision
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DELTEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
JOSTRA
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 7
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 5
Leak 4
Mechanical issue 2
Tube(s), buckling of 2
Replace 1
Component(s), broken 1
Detachment of device component 1
Inaccurate flowrate 1
Total Device Problems 17

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 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Sep-18-2015

-
-