510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NYUClass II

Catheter, Hemodialysis, Implanted, Coated

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NYU is the FDA product code for Catheter, Hemodialysis, Implanted, Coated, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 30 recalls.

Classification record

Product code
NYU
Device name
Catheter, Hemodialysis, Implanted, Coated
FDA definition
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
30

Clearances, product code NYU

By decision year
2 clearances under product code NYU with a decision year between 2006 and 2011, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NYU by decision year
YearClearances
20061
20111

Applicants with the most clearances

Product code NYU
Applicants holding the most 510(k) clearances under product code NYU
ApplicantClearances
Medtronic, Inc.1
Tyco Healthcare Group LP1

Companies listing this code with FDA

Companies whose registered establishments list this code