The following data is part of a premarket notification filed by Spire Biomedical, Inc. with the FDA for 55cm 15.5fr Decathlon Twin Lumen Hemodialysis Catheter W/separated Tips.
| Device ID | K042858 |
| 510k Number | K042858 |
| Device Name: | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK Bedford, MA 01730 -2396 |
| Contact | Donald Fickett |
| Correspondent | Donald Fickett SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK Bedford, MA 01730 -2396 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-15 |
| Decision Date | 2004-12-03 |
| Summary: | summary |