The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angio Jet Ultra Dvx And Xpeedior Thrombectomy Sets.
| Device ID | K091593 |
| 510k Number | K091593 |
| Device Name: | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Doug Atkins |
| Correspondent | Doug Atkins 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-06-22 |
| Summary: | summary |