The following data is part of a premarket notification filed by Control Medical Technology with the FDA for Aspire Max 7 - 11f Mechanical Thrombectomy System And Aspire Mechanical Aspirator.
| Device ID | K200871 |
| 510k Number | K200871 |
| Device Name: | Aspire MAX 7 - 11F Mechanical Thrombectomy System And Aspire Mechanical Aspirator |
| Classification | Catheter, Embolectomy |
| Applicant | Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City, UT 84115 |
| Contact | Shawn Fojtik |
| Correspondent | Shawn Fojtik Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City, UT 84115 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-05-04 |