The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Modification To Guarddog Occlusion System.
| Device ID | K062220 |
| 510k Number | K062220 |
| Device Name: | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Mark D Stenoien |
| Correspondent | Mark D 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-08-11 |
| Summary: | summary |