FDA product code NYU: Catheter, Hemodialysis, Implanted, Coated
NYU is the FDA product code for catheter, hemodialysis, implanted, coated. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under NYU, from 2 different applicants. The average 510(k) review took 73 days (median 73). FDA has posted 30 recalls for NYU devices.
Definition
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, Implanted, Coated |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every NYU clearance
Top NYU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Covidien | 1 | 2011-09-28 |
| Tyco Healthcare Group | 1 | 2006-06-23 |
Most recent NYU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112477 | Covidien | PALINDROME H, SI, HSI CHRONIC CATHETER | 2011-09-28 | 30 |
| K060509 | Tyco Healthcare Group | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING | 2006-06-23 | 116 |
Recalls for NYU devices
30 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-14.
Frequently asked questions
What is FDA product code NYU?
NYU is the FDA product code for catheter, hemodialysis, implanted, coated. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NYU?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYU?
Across 2 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most NYU clearances?
Covidien (1); Tyco Healthcare Group (1).
Have NYU devices been recalled?
Yes: 30 product recalls across 3 recall events; the most recent began 2015-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code NYU
- Run a recall and safety report across every NYU manufacturer
- Watch product code NYU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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