The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for T-anastaflo.
| Device ID | K990396 |
| 510k Number | K990396 |
| Device Name: | T-ANASTAFLO |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | John W Smith |
| Correspondent | John W Smith 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 | 1999-02-09 |
| Decision Date | 1999-10-01 |
| Summary: | summary |