The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Flexor Evac Aspiration Catheter.
| Device ID | K073627 |
| 510k Number | K073627 |
| Device Name: | FLEXOR EVAC ASPIRATION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Karen Bradburn |
| Correspondent | Karen Bradburn COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-03-04 |
| Summary: | summary |