The following data is part of a premarket notification filed by Spire Biomedical, Inc. with the FDA for Retro Silver And Xpresso Silver Chronic Hemodialysis Catheters.
| Device ID | K060288 |
| 510k Number | K060288 |
| Device Name: | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK Bedford, MA 01730 -2396 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly 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 | 2006-02-06 |
| Decision Date | 2006-09-01 |
| Summary: | summary |