The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandemheart Femoral Venous Cannula Set.
| Device ID | K133236 |
| 510k Number | K133236 |
| Device Name: | TANDEMHEART FEMORAL VENOUS CANNULA SET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CARDIAC ASSIST, INC. 240 ALPHA DR. Pgh, PA 15238 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-01-29 |
| Summary: | summary |