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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable, transducer and electrode, patient, (including connector)
Regulation Description Patient transducer and electrode cable (including connector).
Product CodeDSA
Regulation Number 870.2900
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 2
CURBELL ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 1
EUROPEAN CUSTOM MANUFACTURING BV
  SUBSTANTIALLY EQUIVALENT 1
EWC
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
LIFESYNC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MED-DYNE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MINNESOTA MINING AND MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED
  SUBSTANTIALLY EQUIVALENT 2
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 7
Incorrect or inadequate result 3
High impedance 3
Device inoperable 2
Unstable 2
Failure of device to self-test 2
No Known Device Problem 1
Smoking 1
Electrical shorting 1
Defective component 1
Defective item 1
Device displays error message 1
Spark 1
Communication or transmission issue 1
Incorrect measurement 1
Failure to power-up 1
Break 1
Charred 1
Intermittent continuity 1
Total Device Problems 32

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

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Jan-07-2011
2 Remington Medical Inc. II Apr-09-2014
3 Remington Medical Inc. II Aug-13-2010

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