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 |