K921638 is an FDA 510(k) clearance for the SYSTEM 90 INTRA-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 Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on February 10, 1993, 310 days after receiving the submission on April 6, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K921638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1992 |
| Decision Date | February 10, 1993 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSP - System, Balloon, Intra-aortic And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3535 |