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U.S. Department of Health and Human Services

Product Classification

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Device catheters, transluminal coronary angioplasty, percutaneous
Regulation Description Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition A ptca catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLOX
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm225145.htm] 
Third Party Review Not Third Party Eligible
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