Product Classification

• Device: catheter, continuous flush
• Regulation Description: Continuous flush catheter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: KRA
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.1210
• 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 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