The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc with the FDA for Glidepath 13f Long-term Hemodialysis Catheter.
| Device ID | K211410 |
| 510k Number | K211410 |
| Device Name: | GlidePath 13F Long-Term Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Bard Peripheral Vascular, Inc 1625 West 3rd Street Tempe, AZ 85281 |
| Contact | Joan Bergstrom |
| Correspondent | Joan Bergstrom Bard Peripheral Vascular, Inc 1625 West 3rd Street Tempe, AZ 85281 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-06-04 |