The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,model 3030c,lf140 Catheter,model 3040c,pump Set 3020p.
| Device ID | K960970 |
| 510k Number | K960970 |
| Device Name: | POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | POSSIS MEDICAL, INC. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 -2644 |
| Contact | James D Gustafson |
| Correspondent | James D Gustafson POSSIS MEDICAL, INC. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 -2644 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-12-03 |
| Summary: | summary |