K051337 is an FDA 510(k) clearance for the EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX. 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 August 18, 2005, 87 days after receiving the submission on May 23, 2005.
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 | K051337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2005 |
| Decision Date | August 18, 2005 |
| Days to Decision | 87 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. |