The following data is part of a premarket notification filed by Theramed, Inc. with the FDA for Furui Shunt, 2-way And 3-way.
| Device ID | K910004 |
| 510k Number | K910004 |
| Device Name: | FURUI SHUNT, 2-WAY AND 3-WAY |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | THERAMED, INC. P.O. BOX 5886 Ft. Lauderdale, FL 33310 |
| Contact | Charles Hokanson |
| Correspondent | Charles Hokanson THERAMED, INC. P.O. BOX 5886 Ft. Lauderdale, FL 33310 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-02 |
| Decision Date | 1991-09-19 |