Microfilter, Blood Transfusion

Device Code: 2534

Product Code(s): CAK

Device Classification Information

• Device Type ID: 2534
• Device Name: Microfilter, Blood Transfusion
• Regulation Description: Intravascular Administration Set.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5440 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CAK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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
• 6-295 AAMI ANSI BF7:2012
  Blood Transfusion Microfilters
• 6-318 ISO 8536-4 Fifth Edition 2010-10-01
  Infusion Equipment For Medical Use - Part 4: Infusion Sets For Single Use, Gravity Feed [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 2534
• Device: Microfilter, Blood Transfusion
• Product Code: CAK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intravascular Administration Set.
• CFR Regulation Number: 880.5440 [🔎]

Device Problems
Filtration Problem	106
Defective Component	89
Adverse Event Without Identified Device Or Use Problem	55
Restricted Flow Rate	14
Device Operates Differently Than Expected	4
High Test Results	3
Human-Device Interface Problem	2
Material Integrity Problem	1
Nonstandard Device	1
Total Device Problems	275

TPLC Last Update: 2019-04-02 20:13:53