Product Classification

• Device: port & catheter, implanted, subcutaneous, intravascular
• Regulation Description: Subcutaneous, implanted, intravascular infusion port and catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LJT
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5965
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 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
• 6-357 ISO 10555-6 First edition 2015-04-15
  Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
• 6-490 ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019]
  Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]

Third Party Review

Not Third Party Eligible