K911000 is an FDA 510(k) clearance for the PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON. 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 25, 1993, 901 days after receiving the submission on March 8, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K911000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1991 |
| Decision Date | August 25, 1993 |
| Days to Decision | 901 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 |