The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Angiojet Solent Dista Thrombectomy Set.
| Device ID | K113363 |
| 510k Number | K113363 |
| Device Name: | ANGIOJET SOLENT DISTA THROMBECTOMY SET |
| Classification | Catheter, Embolectomy |
| Applicant | MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Contact | Mike Burnside |
| Correspondent | Mike Burnside MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-15 |
| Decision Date | 2012-06-06 |
| Summary: | summary |