The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angiojet Ultra; Xmi (105041), Xvg (105042) And Spiroflex (106553) Thrombectomy Sets.
| Device ID | K072769 |
| 510k Number | K072769 |
| Device Name: | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Mike Burnside |
| Correspondent | Mike Burnside 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 | 2007-09-28 |
| Decision Date | 2007-11-14 |
| Summary: | summary |