DeviceClearance

Product code NYU— Gastroenterology, Urology

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

Classification name
Catheter, Hemodialysis, Implanted, Coated
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.”

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

Market context for product code NYU

FDA has cleared 2 devices under product code NYU between 2006 and 2011, filed by 2 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 NYU

Recent clearances under product code NYU

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