The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Blade Septostomy Catheter.
| Device ID | K801031 |
| 510k Number | K801031 |
| Device Name: | BLADE SEPTOSTOMY CATHETER |
| Classification | Catheter, Septostomy |
| Applicant | COOK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXF |
| CFR Regulation Number | 870.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-01 |
| Decision Date | 1980-07-28 |