The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Park Blade Septostomy Catheter.
| Device ID | K182399 |
| 510k Number | K182399 |
| Device Name: | Park Blade Septostomy Catheter |
| Classification | Catheter, Septostomy |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Rebecca Odulio |
| Correspondent | Rebecca Odulio Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DXF |
| CFR Regulation Number | 870.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-04-04 |