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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous, neurovasculature
Regulation Description Percutaneous catheter.
Definition To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Product CodeQJP
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2

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