The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angiojet Ultra Avx Thrombectomy Set, Model 105039.
| Device ID | K082382 |
| 510k Number | K082382 |
| Device Name: | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Mark Stenoien |
| Correspondent | Mark Stenoien POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. 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 | 2008-08-19 |
| Decision Date | 2008-12-12 |
| Summary: | summary |