K162843 is an FDA 510(k) clearance for the Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II - Special Controls, product code DWB).
Submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on November 17, 2016, 37 days after receiving the submission on October 11, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4370.
| 510(k) Number | K162843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2016 |
| Decision Date | November 17, 2016 |
| Days to Decision | 37 days |
| Submission Type | Special |
| 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 |