K153094 is an FDA 510(k) clearance for the Visions PV .035 Digital IVUS Catheter. This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on December 31, 2015, 66 days after receiving the submission on October 26, 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 | K153094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2015 |
| Decision Date | December 31, 2015 |
| Days to Decision | 66 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. |