The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Guarddog Occlusion System, Occlusion Guidewire, 300 Cm, Guarddog Occlusion System Occlusion Guidewire, 200 Cm.
| Device ID | K031357 |
| 510k Number | K031357 |
| Device Name: | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM |
| Classification | Catheter, Intravascular Occluding, Temporary |
| 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 | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2004-05-18 |
| Summary: | summary |