K120697 is an FDA 510(k) clearance for the EAGLE EYE PLATINUM ST 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 April 5, 2012, 29 days after receiving the submission on March 7, 2012.
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 | K120697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2012 |
| Decision Date | April 05, 2012 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |