The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Possis Angiojet Rapid Thombectomy Catheters--f105 Catheter Model 3030c, Lf140 Catheter Model 3040c.
| Device ID | K972610 |
| 510k Number | K972610 |
| Device Name: | POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | James D Gustafson |
| Correspondent | James D Gustafson 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 | 1997-07-14 |
| Decision Date | 2000-04-11 |
| Summary: | summary |