The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for Alta Lr Fixed Tip Chronic Hemodialysis Catheter, Models Al19nh24, Al23nh28, Al27nh32, Al31nh36, Al35nh40.
| Device ID | K040509 |
| 510k Number | K040509 |
| Device Name: | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Contact | Donald Fickett |
| Correspondent | Donald Fickett SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-04-19 |
| Summary: | summary |