FDA Product Code
FDA Product Code NYU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER | Covidien | 2011-09-28 | Special | PDF ↗ |
| K060509 | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING | Tyco Healthcare Group | 2006-06-23 | Traditional | PDF ↗ |
Product code NYU · Class II · Gastroenterology, Urology. Data: openFDA.