K031636 is an FDA 510(k) clearance for the CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on August 11, 2003, 76 days after receiving the submission on May 27, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K031636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2003 |
| Decision Date | August 11, 2003 |
| Days to Decision | 76 days |
| Submission Type | Abbreviated |
| 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 |