K850482 is an FDA 510(k) clearance for the DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on August 22, 1985, 196 days after receiving the submission on February 7, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K850482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1985 |
| Decision Date | August 22, 1985 |
| Days to Decision | 196 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 |