The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Acute Dual Lumen Hemodialysis Catheter.
| Device ID | K200426 |
| 510k Number | K200426 |
| Device Name: | Acute Dual Lumen Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | Health Line International Corporation 5675 West 300 South Salt Lake City, UT 84104 |
| Contact | Aaron G. Faulkner |
| Correspondent | Aaron G. Faulkner Health Line International Corporation 5675 West 300 South Salt Lake City, UT 84104 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-21 |
| Decision Date | 2020-12-24 |