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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, urological
Regulation Description Urological catheter and accessories.
Product CodeKOD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jul-03-2025
2 C.R. Bard Inc II Feb-24-2022
3 C.R. Bard, Inc. II Apr-16-2021
4 Cardinal Health 200, LLC I Feb-16-2024
5 TELEFLEX LLC II Nov-11-2022
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