K181042 is an FDA 510(k) clearance for the Ultra ICE Plus ? PI 9 MHz Peripheral Imaging Catheter. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on May 17, 2018, 28 days after receiving the submission on April 19, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K181042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2018 |
| Decision Date | May 17, 2018 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |