The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for Venous Flex Ii Peripheral And Intra-operative Access Venous Return Cannulae.
| Device ID | K974259 |
| 510k Number | K974259 |
| Device Name: | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | R D Hibbert |
| Correspondent | R D Hibbert EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-13 |
| Decision Date | 1998-12-01 |
| Summary: | summary |