The following data is part of a premarket notification filed by C R Bard, Inc with the FDA for Glidepath 10f Long-term Dialysis Catheter, Glidepath 7.5f Long-term Dialysis Catheter.
| Device ID | K200627 |
| 510k Number | K200627 |
| Device Name: | GlidePath 10F Long-Term Dialysis Catheter, GlidePath 7.5F Long-Term Dialysis 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 | 2020-03-10 |
| Decision Date | 2020-06-22 |