K971520 is an FDA 510(k) clearance for the S3 CYCLIC RPM CONTROL. 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 September 10, 1997, 138 days after receiving the submission on April 25, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4370.
| 510(k) Number | K971520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1997 |
| Decision Date | September 10, 1997 |
| Days to Decision | 138 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 |