The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Endovascular Dilator And Sets.
| Device ID | K210734 |
| 510k Number | K210734 |
| Device Name: | Endovascular Dilator And Sets |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Michael Venezia |
| Correspondent | Michael Venezia Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-11 |
| Decision Date | 2021-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002132184 | K210734 | 000 |