K943919 is an FDA 510(k) clearance for the 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on March 23, 1995, 223 days after receiving the submission on August 12, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K943919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1994 |
| Decision Date | March 23, 1995 |
| Days to Decision | 223 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 |