NYU · Class II · 21 CFR 876.5540

FDA Product Code NYU: Catheter, Hemodialysis, Implanted, Coated

Accessing The Central Vascular System For Long Term Hemodialysis While Reducing Infection Or Thrombogenesis.

Leading manufacturers include Tyco Healthcare Group and Covidien.

2
Total
2
Cleared
73d
Avg days
2006
Since

FDA 510(k) Cleared Catheter, Hemodialysis, Implanted, Coated Devices (Product Code NYU)

2 devices
1–2 of 2
Cleared Sep 28, 2011
PALINDROME H, SI, HSI CHRONIC CATHETER
K112477
Covidien
Gastroenterology & Urology · 30d
Cleared Jun 23, 2006
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
K060509
Tyco Healthcare Group
Gastroenterology & Urology · 116d

About Product Code NYU - Regulatory Context