The following data is part of a premarket notification filed by Kendall with the FDA for Pallindrome 14.5fr Chronic Hemodialysis Catheter With Slotted Symmetrical Tip.
| Device ID | K043272 |
| 510k Number | K043272 |
| Device Name: | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Jim Welsh |
| Correspondent | Jim 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 | 2004-11-26 |
| Decision Date | 2004-12-22 |
| Summary: | summary |