Product Classification

• Device: catheter, umbilical artery
• Regulation Description: Intravascular catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FOS
• Submission Type: 510(k)
• Regulation Number: 880.5200
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 10555-1 First edtion 1995-06-15 Amendment 1 1999-07-15 Sterile, single-use intravascular catheters - Part 1: General requirements
• ISO 10555-1 First edition 1995-06-5 AMENDMENT 2 2004-05-15 Sterile, single-use intravascular catheters - Part 1: General requirements
• 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

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.