The following data is part of a premarket notification filed by Spire Biomedical, Inc. with the FDA for 15.5fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter With Separated Tips.
| Device ID | K060155 |
| 510k Number | K060155 |
| Device Name: | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH 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 | 2006-01-20 |
| Decision Date | 2006-05-09 |
| Summary: | summary |