Connector, Blood Tubing, Infusion T

Device Code: 1893

Product Code(s): FKB

Device Classification Information

• Device Type ID: 1893
• Device Name: Connector, Blood Tubing, Infusion T
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FKB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-89 ISO 8638 Third Edition 2010-07-01
  Cadiovascular Implants And Extracorporeal Blood Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters

Total Product Life Cycle

• Device Type ID: 1893
• Device: Connector, Blood Tubing, Infusion T
• Product Code: FKB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

Device Problems
Fire	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Perrigo Diabetes Care	II	Feb-19-2014

TPLC Last Update: 2019-04-02 20:01:32