K070225 is an FDA 510(k) clearance for the SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on December 13, 2007, 323 days after receiving the submission on January 24, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K070225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2007 |
| Decision Date | December 13, 2007 |
| Days to Decision | 323 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 |