The following data is part of a premarket notification filed by Medrad Interventional/possis with the FDA for Fetch 2 Aspiration Catheter Model 109400-001.
| Device ID | K101354 |
| 510k Number | K101354 |
| Device Name: | FETCH 2 ASPIRATION CATHETER MODEL 109400-001 |
| Classification | Catheter, Embolectomy |
| Applicant | MEDRAD INTERVENTIONAL/POSSIS 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 |
| Contact | Doug Atkins |
| Correspondent | Doug Atkins MEDRAD INTERVENTIONAL/POSSIS 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2011-01-21 |
| Summary: | summary |