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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reprocessed atherectomy catheter
Definition Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Product CodeQTF
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
NORTHEAST SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

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