K200733 is an FDA 510(k) clearance for the Opticross 35 15 MHz Peripheral Imaging Catheter. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 17, 2020, 28 days after receiving the submission on March 20, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K200733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2020 |
| Decision Date | April 17, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |