The following data is part of a premarket notification filed by Spire Biomedical, Inc. with the FDA for Decathlon Twin Lumen Hemodialysis With Separated Tips, Models De19/24sh, De23/28sh, De27/32sh, De 31/36sh, De19/24nh.
| Device ID | K032061 |
| 510k Number | K032061 |
| Device Name: | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH |
| 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-03 |
| Decision Date | 2003-12-23 |
| Summary: | summary |