K061369 is an FDA 510(k) clearance for the TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 22, 2006, 97 days after receiving the submission on May 17, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K061369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2006 |
| Decision Date | August 22, 2006 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWA — Control, Pump Speed, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4380 |