K113235 is an FDA 510(k) clearance for the PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS. This device is classified as a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II - Special Controls, product code DXS).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 2, 2011, 30 days after receiving the submission on November 2, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4310.
| 510(k) Number | K113235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2011 |
| Decision Date | December 02, 2011 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4310 |