Product Classification

• Device: catheter,intravascular,therapeutic,long-term greater than 30 days
• Regulation Description: Percutaneous, implanted, long-term intravascular catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LJS
• Submission Type: 510(k)
• Regulation Number: 880.5970
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• 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
• ISO 10555-3:1996/ Corrigendum 1:2002 Sterile, single-use intravascular catheters - Part 3: Central venous catheters

Guidance Document

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

Third Party Review

Not Third Party Eligible