The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001.
| Device ID | K090253 |
| 510k Number | K090253 |
| Device Name: | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 |
| Classification | Aspiration Thrombectomy Catheter |
| 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 | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-04-08 |
| Summary: | summary |