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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, portable, aspiration (manual or powered)
Regulation Description Powered suction pump.
Product CodeBTA
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 2
MEDELA HOLDING AG
  SUBSTANTIALLY EQUIVALENT 2
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Charge 2
Failure to Run on Battery 2
Battery Problem 2
No Apparent Adverse Event 2
Tube 1
Thermal Decomposition of Device 1
Device Operational Issue 1
Device Contamination with Chemical or Other Material 1
Improper Flow or Infusion 1
Infusion or Flow Problem 1
Adverse Event Without Identified Device or Use Problem 1
Therapeutic or Diagnostic Output Failure 1
Retraction Problem 1
Failure to Osseointegrate 1
Device Issue 1
Corroded 1
Crack 1
Electrical /Electronic Property Problem 1
Mechanical Problem 1
Total Device Problems 23

Recalls
Manufacturer Recall Class Date Posted
1 MicroAire Surgical Instruments, LLC II Apr-05-2016
2 Ohio Medical Corporation II Sep-07-2018

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