K940178 is an FDA 510(k) clearance for the PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION. 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 9, 1994, 209 days after receiving the submission on January 12, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K940178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1994 |
| Decision Date | August 09, 1994 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| 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 |