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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARDIUM INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Mar-26-2024
2 Medtronic Perfusion Systems II Sep-22-2021
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