The following data is part of a premarket notification filed by Bionomy, Inc. with the FDA for Embolectomy Catheter.
| Device ID | K832023 |
| 510k Number | K832023 |
| Device Name: | EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | BIONOMY, 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 | 1983-06-13 |
| Decision Date | 1983-08-31 |