The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Deseret Subclavian Hemodialysis Catheter.
| Device ID | K881695 |
| 510k Number | K881695 |
| Device Name: | DESERET SUBCLAVIAN HEMODIALYSIS CATHETER |
| Classification | Catheter, Subclavian |
| Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Charles J Welle |
| Correspondent | Charles J Welle DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-06-23 |