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
• Submission Type: 510(k)
• Regulation Number: 880.5965
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• 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

Third Party Review

Not Third Party Eligible