The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Deseret Embolectomy/thrombectomy Cath..
| Device ID | K801650 |
| 510k Number | K801650 |
| Device Name: | DESERET EMBOLECTOMY/THROMBECTOMY CATH. |
| Classification | Catheter, Embolectomy |
| Applicant | DESERET MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-18 |
| Decision Date | 1980-08-04 |