K821065 is an FDA 510(k) clearance for the DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on August 19, 1982, 126 days after receiving the submission on April 15, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K821065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1982 |
| Decision Date | August 19, 1982 |
| Days to Decision | 126 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 |