K911384 is an FDA 510(k) clearance for the CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on June 25, 1991, 89 days after receiving the submission on March 28, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K911384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1991 |
| Decision Date | June 25, 1991 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |