The following data is part of a premarket notification filed by Spire Biomedical, Inc. with the FDA for Repair Kit For Xpresso, Decathlon, And Alta Lr Catheters.
| Device ID | K062435 |
| 510k Number | K062435 |
| Device Name: | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS |
| Classification | Kit, Repair, Catheter, Hemodialysis |
| Applicant | SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK Bedford, MA 01730 -2396 |
| Contact | Shekhar Nimkar |
| Correspondent | Shekhar Nimkar SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK Bedford, MA 01730 -2396 |
| Product Code | NFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2006-12-05 |
| Summary: | summary |