K092596 is an FDA 510(k) clearance for the EAGLE EYE PLATINUM DIGITAL IVUS CATHETER. This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on December 10, 2009, 108 days after receiving the submission on August 24, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K092596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2009 |
| Decision Date | December 10, 2009 |
| Days to Decision | 108 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| 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. |