Product Classification

• Device: catheter, intravascular, therapeutic, short-term less than 30 days
• Regulation Description: Intravascular catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FOZ
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5200
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 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
• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-303 ISO 10555-5 Second edition 2013-06-15
  Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
• 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)]
• 6-498 ISO 10555-4 Third edition 2023-11
  Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
• 6-499 ISO 10555-1 Third edition 2023-11
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Guidance Documents

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

• Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA

• Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc