System, Blood, Extracorporeal And Accessories

Device Code: 1989

Product Code(s): LLB

Device Classification Information

• Device Type ID: 1989
• Device Name: System, Blood, Extracorporeal And Accessories
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LLB
• 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: 1989
• Device: System, Blood, Extracorporeal And Accessories
• Product Code: LLB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Nipro Medical Corporation	II	Oct-23-2015

TPLC Last Update: 2019-04-02 20:03:27