The following data is part of a premarket notification filed by Kendall with the FDA for 14.5 Fr Chronic Hemodialysis Catheter With Insertion Stylets Accessory.
| Device ID | K051584 |
| 510k Number | K051584 |
| Device Name: | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | James Welsh |
| Correspondent | James Welsh KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-10-06 |
| Summary: | summary |