K042374 is an FDA 510(k) clearance for the STOCKERT SCP RHYTHM. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Stockert Instrumente GmbH (North Attleboro, US). The FDA issued a Cleared decision on September 23, 2004, 22 days after receiving the submission on September 1, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K042374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2004 |
| Decision Date | September 23, 2004 |
| Days to Decision | 22 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 |