Product Classification

• Device: catheter, angioplasty, peripheral, transluminal, dual-balloon
• Regulation Description: Percutaneous catheter.
• Definition: Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
• Physical State: Comprised of a catheter body with two concentric distal inflatable balloons.
• Technical Method: Used independently for dilation or dilatation of diseased peripheral vasculature to restore blood flow
• Target Area: Peripheral vasculature exclusive of coronary arteries.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: NVM
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.1250
• 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

Guidance Document

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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc