K153617 is an FDA 510(k) clearance for the OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution). This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Boston Scientific Corporation (Fremont, US). The FDA issued a Cleared decision on February 25, 2016, 69 days after receiving the submission on December 18, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K153617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2015 |
| Decision Date | February 25, 2016 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |