K041558 is an FDA 510(k) clearance for the STOCKERTIR PURGE CONTROL (APC) SYSTEM. This device is classified as a Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (Class II - Special Controls, product code DTW).
Submitted by Stockert Instrumente GmbH (North Attleboro, US). The FDA issued a Cleared decision on July 2, 2004, 22 days after receiving the submission on June 10, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4340.
| 510(k) Number | K041558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2004 |
| Decision Date | July 02, 2004 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTW — Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4340 |