The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Cascade Hemodialysis/apheresis Catheter.
| Device ID | K130851 |
| 510k Number | K130851 |
| Device Name: | CASCADE HEMODIALYSIS/APHERESIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
| Contact | Nola Benstog |
| Correspondent | Nola Benstog HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-27 |
| Decision Date | 2014-01-09 |
| Summary: | summary |