Product Classification

• 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 Code: LOX
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.5100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 3-172 AAMI TIR42:2021
  Evaluation of Particulates Associated with Vascular Medical Devices

Guidance Documents

• Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters

• Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible