K170029 is an FDA 510(k) clearance for the FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by International Biophysics Corporation (Austin, US). The FDA issued a Cleared decision on December 15, 2017, 345 days after receiving the submission on January 4, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K170029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2017 |
| Decision Date | December 15, 2017 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KFM - Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4360 |