The following data is part of a premarket notification filed by Canyon Medical Products with the FDA for Canyon Medical Femoral Bypass Cannulae And Intro..
| Device ID | K897026 |
| 510k Number | K897026 |
| Device Name: | CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CANYON MEDICAL PRODUCTS 3706 WEST 2100 SOUTH Salt Lake City, UT 84120 |
| Contact | Steven M Smith |
| Correspondent | Steven M Smith CANYON MEDICAL PRODUCTS 3706 WEST 2100 SOUTH Salt Lake City, UT 84120 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-19 |
| Decision Date | 1990-02-26 |