The following data is part of a premarket notification filed by Tyco Healthcare Group with the FDA for Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter With Heparin Coating.
| Device ID | K060509 |
| 510k Number | K060509 |
| Device Name: | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING |
| Classification | Catheter, Hemodialysis, Implanted, Coated |
| Applicant | TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Keith Martin |
| Correspondent | Keith Martin TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NYU |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-02-27 |
| Decision Date | 2006-06-23 |
| Summary: | summary |