The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Possis Angiojet X-stream Rheolytic Thrombectomy Catheter, Model 103587-002.
| Device ID | K993564 |
| 510k Number | K993564 |
| Device Name: | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Timothy J Kappers |
| Correspondent | Timothy J Kappers POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 2000-04-28 |
| Summary: | summary |