Product Classification

• Device: microfilter, blood transfusion
• Regulation Description: Intravascular administration set.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: CAK
• Submission Type: 510(k)
• Regulation Number: 880.5440
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI BF7:1989/ (R) 2011 Blood transfusion micro-filters
• ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
• 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

Guidance Document

• Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]

Third Party Review

Not Third Party Eligible