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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, assisted reproduction
Regulation Description Assisted reproduction catheters.
Product CodeMQF
Regulation Number 884.6110
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 7
FERTILIGENT, LTD
  SUBSTANTIALLY EQUIVALENT 1
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDGYN
  SUBSTANTIALLY EQUIVALENT 1
MEDGYN PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Contamination with Chemical or Other Material 20
Contamination /Decontamination Problem 18
Catheter 10
Device Contaminated During Manufacture or Shipping 6
Material Separation 5
Device Operates Differently Than Expected 3
Break 3
Material Too Rigid or Stiff 2
Difficult to Advance 2
Tip 1
Bent 1
Packaging Problem 1
Nonstandard Device 1
Unsealed Device Packaging 1
Appropriate Term/Code Not Available 1
Total Device Problems 75

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Nov-16-2019
2 Cook Inc. II Mar-26-2018

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