The following data is part of a premarket notification filed by Kendall with the FDA for 14.5 Fr Chronic Hemodialysis Catheter With Heparin Coating And Silver Impregnated Sleeve (palindrome Sapphire).
| Device ID | K062671 |
| 510k Number | K062671 |
| Device Name: | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Keith Martin |
| Correspondent | Keith Martin KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-09-08 |
| Decision Date | 2006-11-03 |
| Summary: | summary |