K190101 is an FDA 510(k) clearance for the UltraFlex IAB. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Arrow International, Inc. (Chelmsford, US). The FDA issued a Cleared decision on June 28, 2019, 157 days after receiving the submission on January 22, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K190101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | June 28, 2019 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSP - System, Balloon, Intra-aortic And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3535 |