Product Classification

• Device: catheter, angioplasty, peripheral, transluminal
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: LIT
• Premarket Review: Coronary and Peripheral Interventional Devices (DHT2C); 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

Recognized Consensus Standards

• 3-172 AAMI TIR42:2021
  Evaluation of Particulates Associated with Vascular Medical Devices
• 3-176 ISO 18193 First edition 2021-08
  Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
• 3-183 ISO 11658 First edition 2012-05-15
  Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
• 6-322 ISO 10555-4 Second edition 2013-06-15
  Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
• 6-408 ISO 10555-1 Second edition 2013-06-15
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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