K955038 is an FDA 510(k) clearance for the STOCKERT S3 DOUBLE HEAD PUMP MODULE. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II - Special Controls, product code DWB).
Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on February 21, 1996, 110 days after receiving the submission on November 3, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4370.
| 510(k) Number | K955038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1995 |
| Decision Date | February 21, 1996 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4370 |