The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fogarty Vessel Calibrator.
| Device ID | K902143 |
| 510k Number | K902143 |
| Device Name: | FOGARTY VESSEL CALIBRATOR |
| Classification | Dilator, Vessel, Surgical |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | H Bergeson |
| Correspondent | H Bergeson BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-10-16 |