Product Classification

• Device: introducer, catheter
• Regulation Description: Catheter introducer.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DYB
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.1340
• 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