The following data is part of a premarket notification filed by Canyon Medical Products with the FDA for Canyon Medical Femoral Bypass Cannulae.
| Device ID | K874899 |
| 510k Number | K874899 |
| Device Name: | CANYON MEDICAL FEMORAL BYPASS CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CANYON MEDICAL PRODUCTS 2850 EAST 7320 SOUTH Salt Lake City, UT 84121 |
| Contact | Steven M Smith |
| Correspondent | Steven M Smith CANYON MEDICAL PRODUCTS 2850 EAST 7320 SOUTH Salt Lake City, UT 84121 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1988-02-18 |