Product Classification

• Device: heparin, vascular access flush
• Regulation Description: Intravascular catheter.
• Definition: Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
• Physical State: Liquid solution
• Technical Method: Physically occupies spacewithin the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting.
• Target Area: Vascular catheter
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: NZW
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• 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: Eligible
• 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
• 6-408 ISO 10555-1 Second edition 2013-06-15
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
• 6-472 USP-NF M36660_04_01
  Heparin Lock Flush Solution
• 6-499 ISO 10555-1 Third edition 2023-11
  Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements

Third Party Review

Not Third Party Eligible