The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Vessel Dilator.
| Device ID | K832595 |
| 510k Number | K832595 |
| Device Name: | VESSEL DILATOR |
| Classification | Dilator, Vessel, Surgical |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-08-31 |