K896597 is an FDA 510(k) clearance for the THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on February 12, 1990, 83 days after receiving the submission on November 21, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K896597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1989 |
| Decision Date | February 12, 1990 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSP — System, Balloon, Intra-aortic And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3535 |