The following data is part of a premarket notification filed by C B Bard, Inc with the FDA for Pristine Long-term Hemodialysis Catheter.
| Device ID | K203767 |
| 510k Number | K203767 |
| Device Name: | Pristine Long-Term Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | C B Bard, Inc 1625 W Third Street Tempe, AZ 85281 |
| Contact | Arieona Boyle |
| Correspondent | Arieona Boyle C B Bard, Inc 1625 W Third Street Tempe, AZ 85281 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-04-02 |