DeviceClearance

Product code NIE— Gastroenterology, Urology

12F Tri-Flow Triple Lumen Catheter

Classification name
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Total cleared
12
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NIE under 21 CFR 876.5540, via openFDA

Market context for product code NIE

FDA has cleared 12 devices under product code NIE between 2002 and 2023, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NIE

Adverse events under product code NIE

product code NIE
Death
9
Other
1
Total
10

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NIE

Data sourced from openFDA. This site is unofficial and independent of the FDA.