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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reprocessed catheter introducer
Regulation Description Catheter introducer.
Definition Introduce various cardiovascular catheters into the heart and cardiovascular system
Product CodePNE
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
STERILMED
  SUBSTANTIALLY EQUIVALENT 1

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