The following data is part of a premarket notification filed by Kendall with the FDA for Kedall 14.5 Fr Chronic Hemodialysis Catheter W/silver Impregnated Sleeve (palindrome Ruby).
| Device ID | K060972 |
| 510k Number | K060972 |
| Device Name: | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-04-07 |
| Decision Date | 2006-08-04 |
| Summary: | summary |