The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307.
| Device ID | K071336 |
| 510k Number | K071336 |
| Device Name: | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Frank B Freedman |
| Correspondent | Frank B Freedman 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 | 2007-05-11 |
| Decision Date | 2007-08-24 |
| Summary: | summary |