The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Angiojet Solent Omni Thrombectomy Set.
| Device ID | K111182 |
| 510k Number | K111182 |
| Device Name: | ANGIOJET SOLENT OMNI THROMBECTOMY SET |
| Classification | Catheter, Embolectomy |
| Applicant | MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Contact | Doug Atkins |
| Correspondent | Doug Atkins MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2011-05-24 |
| Summary: | summary |