The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandem Heart Escort (t.h.e.) Controller, Model 5140-8500.
| Device ID | K061369 |
| 510k Number | K061369 |
| Device Name: | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Robert Bollinger |
| Correspondent | Robert Bollinger CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-17 |
| Decision Date | 2006-08-22 |
| Summary: | summary |