The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter.
| Device ID | K013160 |
| 510k Number | K013160 |
| Device Name: | POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-21 |
| Decision Date | 2002-04-11 |
| Summary: | summary |