The following data is part of a premarket notification filed by C.r. Bard with the FDA for Glidepath Long-term Hemodialysis Catheters, Hemostar Long-term Hemodialysis Catheters, Hemostar Xk Long-term Hemodialysis Catheters.
| Device ID | K190527 |
| 510k Number | K190527 |
| Device Name: | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | C.R. Bard 605 N 5600 W Salt Lake City, UT 84116 |
| Contact | Jonathan Holmes |
| Correspondent | Joan Bergstrom Bard Access Systems, Inc. 1625 West 3rd Street Tempe, UT 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 | 2019-03-04 |
| Decision Date | 2020-03-05 |