The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Glidepath Retro Long-term Hemodialysis Catheter.
| Device ID | K203575 |
| 510k Number | K203575 |
| Device Name: | GlidePath Retro Long-Term Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | C.R. Bard, Inc. 1625 W. Third Street Tempe, AZ 85281 |
| Contact | Joan Bergstrom |
| Correspondent | Joan Bergstrom C.R. 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 | 2020-12-07 |
| Decision Date | 2021-07-01 |