NIE — Catheter, Hemodialysis, Triple Lumen, Non-Implanted

21 CFR 876.5540

Class 2 Life-Sustaining

Definition

Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

Medical Specialty

GU

Review Panel

GU

Submission Type

1

FDA Authorisations (12)

Device Name K-Number
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions K232945
Power Acute Triple Lumen Hemodialysis Catheter K222170
Trio-CT Triple Lumen Catheter K183219
12F Tri-Flow Triple Lumen Catheter K181175
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions K143102
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER K141531
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER K133456
T3 K123292
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER K102605
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER K083675
MEDCOMP T-3 K033570
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR K020089